Active drive for robotic catheter manipulators

ABSTRACT

An instrument driver comprises a base and a jaw assembly coupled to the base. The jaw assembly includes a first jaw having a gripping surface and a second jaw having a gripping surface. The instrument driver further comprises a driver assembly operably coupled to the jaw assembly to advance an elongated member relative to the base by translating the first and second jaws toward each other, thereby closing the jaw assembly and gripping the member between the respective gripping surfaces of the first and second jaws, translating the jaw assembly in a first axial direction when the jaw assembly is closed, translating the first and second jaws away from each other, thereby opening the jaw assembly and releasing the member from between the respective gripping surfaces of the first and second jaws, and translating the jaw assembly in a second axial direction when the jaw assembly is opened.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/803,535, entitled “ACTIVE DRIVES FOR ROBOTIC CATHETER MANIPULATORS,”filed Mar. 14, 2013. The entirety of the above-reference application ishereby incorporated by reference.

FIELD OF INVENTION

The invention relates robotic catheter manipulators, and moreparticularly to drive mechanisms for inserting/retracting catheters insuch robotic catheter manipulators.

BACKGROUND

Minimally invasive procedures are preferred over conventional techniqueswherein the patient's body cavity is open to permit the surgeon's handsaccess to internal organs. Thus, there is a need for a highlycontrollable yet minimally sized system to facilitate imaging,diagnosis, and treatment of tissues which may lie deep within a patient,and which may be accessed via naturally-occurring pathways, such asblood vessels, other lumens, via surgically-created wounds of minimizedsize, or combinations thereof.

Currently known minimally invasive procedures for the treatment ofcardiac, vascular, and other disease conditions use manually orrobotically actuated instruments, which may be inserted transcutaneouslyinto body spaces such as the thorax or peritoneum, transcutaneously orpercutaneously into lumens such as the blood vessels, through naturalorifices and/or lumens such as the mouth and/or upper gastrointestinaltract, etc. Manually and robotically-navigated interventional systemsand devices, such as steerable catheters, are well suited for performinga variety of minimally invasive procedures. Manually-navigated cathetersgenerally have one or more handles extending from their proximal endwith which the operator may steer the pertinent instrument.Robotically-navigated catheters may have a proximal interface configuredto interface with a catheter driver comprising, for example, one or moremotors configured to induce navigation of the catheter in response tocomputer-based automation commands input by the operator at a masterinput device in the form of a work station.

In the field of electrophysiology, robotic catheter navigation systems,such as the Sensei® Robotic Catheter System (manufactured by HansenMedical, Inc.), have helped clinicians gain more catheter control thataccurately translates the clinician's hand motions at the workstation tothe catheter inside the patient's heart, reduce overall procedures(which can last up to four hours), and reduce radiation exposure due tofluoroscopic imaging necessary to observe the catheter relative to thepatient anatomy, and in the case of electrophysiology, within therelevant chamber in the heart. The Sensei® Robotic Catheter Systememploys a steerable outer catheter and a steerable innerelectrophysiology (EP) catheter, which can be manually introduced intothe patient's heart in a conventional manner. The outer and innercatheters are arranged in an “over the wire” telescoping arrangementthat work together to advance through the tortuous anatomy of thepatient. The outer catheter, often referred to as a guiding sheath,provides a steerable pathway for the inner catheter. Proximal adapterson the outer guide sheath and inner EP catheter can then be connected tothe catheter driver, after which the distal ends of the outer sheath andinner EP catheter can be robotically manipulated in the heart chamberwithin six degrees of freedom (axial, roll, and pitch for each) viaoperation of the Sensei® Robotic Catheter System.

While the Sensei® Robotic Catheter System is quite useful in performingrobotic manipulations at the operational site of the patient, it isdesirable to employ robotic catheter systems capable of allowing aphysician to access various target sites within the human vascularsystem. In contrast to the Sensei® Robotic Catheter System, which isdesigned to perform robotic manipulations within open space (i.e.,within a chamber of the heart) after the outer guide sheath and innercatheter are manually delivered into the heart via a relativelynon-tortuous anatomical route (e.g., via the vena cava), and thereforemay be used in conjunction with sheaths and catheters that are bothaxially and laterally rigid, robotic catheter systems designed tofacilitate access to the desired target sites in the human vascularsystem require simultaneous articulation of the distal tip withcontinued insertion or retraction of an outer guide sheath and an innercatheter. As such, the outer guide sheath and inner catheter should belaterally flexible, but axially rigid to resist the high axial loadsbeing applied to articulate the outer guide sheath or inner catheter, inorder to track through the tortuous anatomy of the patient. In thisscenario, the inner catheter, sometimes called the leader catheterextends beyond the outer sheath and is used to control and bend aguidewire that runs all the way through the leader catheter in anover-the-wire configuration. The inner catheter also works inconjunction with the outer guide sheath and guidewire in a telescopingmotion to inchworm the catheter system through the tortuous anatomy.Once the guidewire has been positioned beyond the target anatomicallocation, the leader catheter is usually removed so that a therapeuticdevice can be passed through the steerable sheath and manually operated.

Robotically navigating a guide sheath, an inner catheter, and aguidewire through the anatomy of a patient, in contrast to roboticallymanipulating a guide sheath and inner catheter at a work site in whichthese devices have previously been manually delivered, increases thecomplexity of the robotic catheter system. For example, as shown in FIG.1, robotic catheter systems typically employ a robotic instrument driver1 to provide robotic insertion and retraction actuation, as well asrobotic steering actuation, to a telescoping assembly of elongatedflexible instruments. The instrument driver 1 comprises a housing 2 thatcontains motors (not shown) for providing the robotic actuators to thetelescoping assembly, which may include an outer steerable guide sheath3, an inner steerable leader catheter 4 disposed within the sheathcatheter, and a conventional guidewire 5 disposed within the leadercatheter 2.

The robotic instrument driver 1 may robotically insert/retract theleader catheter 2 relative to the sheath catheter 1. To this end, theproximal ends of the guide sheath 3 and leader catheter 4 aremechanically interfaced to the housing 2 of the instrument driver 1 insuch a manner that they may be axially translated relative to each othervia operation of the motors, thereby effecting insertion or retractionmovements of the respective guide sheath 3 and leader catheter 4. In theillustrated embodiment, the guide sheath 3 and leader catheter 4respectively include proximal steering adapters 6, 7 (“splayers”)mounted to associated mounting plates 8, 9 on a top portion of theinstrument driver 1. The mounting plate 8 is affixed to the distal endof the instrument driver 1, whereas the mounting plate 9 is affixed to acarriage (not shown) within the housing 2 of the instrument driver 1that can be translated relative to the mounting plate 8 via one or moremotors (not shown) within the housing 2 of the instrument driver 1,thereby allowing the proximal steering adapter 7 to be translatedrelative to the proximal steering adapter 6, and thus, the associatedleader catheter 4 to be inserted/retracted within the guide sheath 3. Inthe illustrated embodiment, each of the proximal adapters 6, 7 can beactuated via motors (not shown) within the housing 2 of the instrumentdriver 1 to deflect or articulate the distal ends of the respective inany direction.

Unlike the steerable guide sheath 3 and leader catheter 4, the distalends of which can be robotically articulated via the instrument driver1, the guidewire 5 is conventional, and thus, its distal end is notcapable of being robotically articulated. Instead, as with mostconventional guidewires, the guidewire 5 may be manipulated bysimultaneously rolling while axially displacing the guidewire. In anon-robotic environment, such manipulations can be accomplished bypinching the proximal end of the guidewire between the forefinger andthumb of the physician and moving the forefinger relative to the thumbwhile axially displacing the guidewire.

In order to navigate the guide sheath 3 and leader catheter 4 throughthe tortuous anatomy of a patient, it is desirable that these componentsbe laterally flexible. However, the flexibility of the leader catheter 4may create issues when performing the robotic insertion actuation. Inparticular, due to the flexibility of the leader catheter 4 and therelatively long distance between the mounting plate 9 and the point atwhich the leader catheter 4 is contained within the guide sheath 3,translation of the mounting plate 9 towards the mounting plate 8 withthe intention of inserting the leader catheter 4 within the guide sheath3 may actually cause the leader catheter 4 to buckle, thereby preventingit, or at least hindering it, from axially translating within the guidesheath 3. Although “passive” anti-buckling devices may be used to addlateral support to the leader catheter 4, thereby preventing the leadercatheter 4 from buckling, these anti-buckling devices may be toocumbersome and time-consuming for medical personnel to install.

Furthermore, emulating a manual guidewire manipulation in a roboticcatheter system is not a straightforward procedure. For example,although the instrument driver 1 illustrated in FIG. 1 can be designedto robotically insert/retract the guidewire 5 relative to the leadercatheter 4 in the same manner in which the instrument 1 uses torobotically insert/retract the leader catheter 4 relative to the guidesheath 3, such an arrangement may be impractical. In particular, theincorporation of an additional carriage within the housing 2 willdisadvantageously increase the length of the instrument driver 1, whichmust accommodate the telescoping assembly when assuming a maximumretraction between the leader catheter 4 and guide sheath 3 and betweenthe guidewire 5 and leader catheter 4. The increased size of theinstrument driver 1 may be impractical and too big and heavy to bemounted on a table in a catheter lab environment. Thus, it is preferablethat any drive device that inserts/retracts the guidewire 5 relative tothe leader catheter 4 be immobile relative to the proximal end of theleader catheter 4, e.g., by locating it on the same carriage that isassociated with the leader catheter 4. This drive device must also becapable of rolling the guidewire 5.

Furthermore, the use of an additional carriage for the guidewire 5 wouldalso require the installation of an additional “passive” anti-bucklingdevice. Because medical personnel often exchange out guidewires that areas long as 300 cm in length, the use of a “passive” anti-buckling devicenot only may be tedious for medical personnel to install, the extendedlength of the anti-buckling device due to the length of the guidewiremay render the anti-buckling device functionally impractical.

There, thus, remains a need to provide an improved an instrument driverfor a robotic catheter system that prevents a leader catheter frombuckling when inserted within a guide sheath and/or prevents a guidewirefrom buckling when inserted within a leader catheter without overlyincreasing the length of the instrument driver.

SUMMARY OF THE INVENTION

In accordance with a first aspect of the present inventions, a medicalsystem comprises a telescoping catheter assembly comprising an outerguide sheath and an inner catheter. The outer guide sheath includes anelongated sheath body and a proximal sheath adapter affixed to thesheath body, and the inner catheter includes an elongated catheter bodyand a proximal catheter adapter affixed to the catheter body.

The medical system further comprises an instrument driver comprising asheath interface to which the proximal sheath adapter is configured forbeing mated, and a slidable carriage to which the proximal catheteradapter is configured for being mated. In one embodiment, the proximalsheath adapter and proximal catheter adapter are respectively configuredfor being releasably mated to the sheath interface and slidablecarriage.

The instrument driver further includes a feeder mechanism affixedbetween the sheath interface and slidable carriage for engaging thecatheter body. In one embodiment, the feeder mechanism is affixedrelative to the sheath interface. In another embodiment, the feedermechanism comprises at least one pair of opposing gripping elementsconfigured for engaging the catheter body. Each pair of opposinggripping element(s) may comprise a pair of opposing gripping padsconfigured for being linearly translated to actively advance thecatheter body within the sheath body. Or, each pair of opposing grippingelement(s) may comprise a pair of opposing rotatable gripping padsconfigured for being rotated opposite to each other to actively advancethe catheter body within the sheath body. In either case, the feedermechanism may be configured for actively advancing the catheter bodywithin the sheath body at an infinite linear range.

The instrument driver further includes at least one motor configured fortranslating the slidable carriage distally towards the sheath interfaceto translate the proximal catheter adapter towards the proximal sheathadapter while operating the feeder mechanism to actively advance thecatheter body within the sheath body. In one embodiment, the motor(s) isconfigured for translating the slidable carriage distally away fromsheath interface to translate the proximal catheter adapter away fromthe proximal sheath adapter while operating the feeder mechanism toactively retract the catheter body within the sheath body. The motor(s)may optionally be configured for operating each of the proximal sheathadapter and the proximal catheter adapter to respectively articulatedistal ends of the sheath body and the catheter body. The instrumentdriver may further comprise a housing containing the motor(s).

In an optional embodiment, the telescoping catheter assembly furthercomprises a guidewire, and the instrument driver further comprises adrive mechanism configured for engaging the guidewire. In this case, themotor(s) is configured for operating the drive mechanism to advance theguidewire within the catheter body. The motor(s) may further beconfigured for operating the drive mechanism to simultaneously advancethe guidewire within the catheter body and roll the guidewire about alongitudinal axis. In one embodiment, the instrument driver is a roboticinstrument driver, in which case, medical system may further comprise amaster input device configured for receiving commands from a user, and acomputer configured for controlling the robotic instrument driver inaccordance with the user commands.

In accordance with a second aspect of the present inventions, aninstrument driver for a telescoping catheter assembly is provided. Thetelescoping catheter assembly comprises an outer guide sheath and aninner catheter. The outer guide sheath includes an elongated sheath bodyand a proximal sheath adapter affixed to the sheath body, and the innercatheter includes an elongated catheter body and a proximal catheteradapter affixed to the catheter body.

The instrument driver comprises a sheath interface to which the proximalsheath adapter is configured for being mated, and a slidable carriage towhich the proximal catheter adapter is configured for being mated. Inone embodiment, the proximal sheath adapter and proximal catheteradapter are respectively configured for being releasably mated to thesheath interface and slidable carriage.

The instrument driver further comprises a feeder mechanism affixedbetween the sheath interface and slidable carriage and being configuredfor engaging the catheter body. In one embodiment, the feeder mechanismis affixed relative to the sheath interface. In another embodiment, thefeeder mechanism comprises at least one pair of opposing grippingelements configured for engaging the catheter body. Each pair ofopposing gripping element(s) may comprise a pair of opposing grippingpads configured for being linearly translated to actively advance thecatheter body within the sheath body. Or, each pair of opposing grippingelement(s) may comprise a pair of opposing rotatable gripping padsconfigured for being rotated opposite to each other to actively advancethe catheter body within the sheath body. In either case, the feedermechanism may be configured for actively advancing the catheter bodywithin the sheath body at an infinite linear range.

The instrument driver further comprises at least one motor configuredfor translating the slidable carriage distally towards the sheathinterface to translate the proximal catheter adapter towards theproximal sheath adapter while operating the feeder mechanism to activelyadvance the catheter body within the sheath body. In one embodiment, themotor(s) is configured for translating the slidable carriage distallyaway from sheath interface to translate the proximal catheter adapteraway from the proximal sheath adapter while operating the feedermechanism to actively retract the catheter body within the sheath body.The motor(s) may optionally be configured for operating each of theproximal sheath adapter and the proximal catheter adapter torespectively articulate distal ends of the sheath body and the catheterbody. The instrument driver may further comprise a housing containingthe motor(s).

In accordance with a third aspect of the present invention, aninstrument driver for use with an elongated member (e.g., an elongatedmedical device, such as a steerable catheter and/or a balloon or stentdelivery catheter) is provided. The instrument driver comprises a base,and a jaw assembly coupled to the base. The jaw assembly includes afirst jaw having a gripping surface, and a second jaw having a grippingsurface. Each of the first and second jaws may have a gripping padhaving the gripping surface disposed thereon. In one embodiment, theinstrument driver may further comprise a housing containing the jawassembly and the driver assembly.

The instrument driver further comprises a driver assembly operablycoupled to the jaw assembly to advance the elongated member relative tothe base by translating the first and second jaws toward each other,thereby closing the jaw assembly and gripping the elongated memberbetween the respective gripping surfaces of the first and second jaws,translating the jaw assembly in a first axial direction when the jawassembly is closed, translating the first and second jaws away from eachother, thereby opening the jaw assembly and releasing the elongatedmember from between the respective gripping surfaces of the first andsecond jaws, and translating the jaw assembly in a second axialdirection opposite to the first axial direction when the jaw assembly isopened.

In one embodiment, the driver assembly is configured for translating thejaw assembly in the first axial direction from a reference position whenthe jaw assembly is closed, and for translating the jaw assembly in thesecond axial direction back to the reference position when the jawassembly is opened. The drive assembly may be configured for cyclicallyrepeating the translation steps to repeatedly axially translate theelongate member relative to the base. In another embodiment, the driverassembly is operably coupled to the jaw assembly to retract theelongated member relative to the base by translating the first andsecond jaws toward each other, thereby closing the jaw assembly andgripping the elongated member between the respective gripping surfacesof the first and second jaws, translating the jaw assembly in the secondaxial direction when the jaw assembly is closed, translating the firstand second jaws away from each other, thereby opening the jaw assemblyand releasing the elongated member from between the respective grippingsurfaces of the first and second jaws, and translating the jaw assemblyin the first axial direction opposite to the first axial direction whenthe jaw assembly is opened.

In still another embodiment, the driver assembly may include a camfollower element including a first groove, a second groove, a firstbearing surface, and a second bearing surface. The drive assembly mayfurther include a cam shaft rotatably mounted to the base and operablycoupled to the cam follower element. In this case, the cam shaft has alinear cam and first and second oppositely pitched helical cams, and isconfigured for being rotated relative to the base in a first rotationaldirection in a manner that engages the linear cam against the firstbearing surface, thereby translating the gripping surface of the firstjaw towards the gripping surface of the second jaw to close the jawassembly, that engages the first helical cam within the first groove,thereby translating the jaw assembly in the first axial direction whenthe jaw assembly is closed, that engages the linear cam against thesecond bearing surface, thereby translating the gripping surface of thefirst jaw away from the gripping surface of the second jaw to open thejaw assembly, and that engages the second helical cam within the secondgroove, thereby translating the first jaw in the second axial directionopposite to the first axial direction when the jaw assembly is opened.The cross-sections of the first and second grooves may be V-shaped, andthe first bearing surface and the second bearing surface may becircumferentially located on opposite sides of the cam shaft, and mayhave the same circumferential orientation on the cam shaft. The driverassembly may further include a motor configured for rotating the camshaft relative to the base.

In an optional embodiment, the instrument driver comprises a pluralityof jaw assemblies (e.g., three) coupled to the base, with each jawassembly including a first jaw having a gripping surface, and a secondjaw having a gripping surface. In this case, the driver assembly isoperably coupled to each of the plurality of jaw assemblies to advancethe elongated member relative to the base by translating the first andsecond jaws of the each jaw assembly toward each other, thereby closingthe each jaw assembly and gripping the elongated member between therespective gripping surfaces of the first and second jaws of the eachjaw assembly, translating the each jaw assembly in a first axialdirection when the each jaw assembly is closed, translating the firstand second jaws of the each jaw assembly away from each other, therebyopening the each jaw assembly and releasing the elongated member frombetween the respective gripping surfaces of the first and second jaws ofthe each jaw assembly, and translating the each jaw assembly in a secondaxial direction opposite to the first axial direction when the each jawassembly is opened. Preferably, at least one the jaw assemblies isalways closed during operation of the driver assembly, such that theelongated member is continuously translated in the first axialdirection.

The instrument driver may be for use with a telescoping assemblycomprising an outer elongated medical instrument and an inner elongatedmedical instrument. The outer medical instrument includes an outerelongated body and a proximal adapter affixed to the outer elongatedbody, and the inner medical instrument includes the aforementionedelongated member. In this case, the instrument driver comprises ahousing on which the base is mounted; and an interface mounted to thehousing and configured for being mated with the proximal adapter of theouter medical instrument. The inner elongated body is configured forbeing advanced within the outer elongated body when the jaw assembly istranslated in the first axial direction. The inner medical instrumentmay further have a proximal adapter affixed to the elongated member, inwhich case, the instrument driver further comprises a slidable carriageto which the proximal adapter of the inner medical instrument isconfigured for being mated, and at least one motor configured fortranslating the slidable carriage distally towards the sheath interfaceto translate the proximal catheter adapter towards the proximal sheathadapter while operating the cam shaft to translate the jaw assembly inthe first axial direction. The instrument driver may be a roboticinstrument driver incorporated into a medical system comprising a masterinput device configured for receiving commands from a user, and acomputer configured for controlling the robotic instrument driver inaccordance with the user commands.

In accordance with a fourth aspect of the present inventions, anotherinstrument driver for use with an elongated member (e.g., an elongatedmedical device, such as a steerable catheter and/or a balloon or stentdelivery catheter) is provided. The instrument driver comprises a baseand three jaw assemblies coupled to the base in an aligned manner. Eachof the jaw assemblies includes a first jaw having a gripping surface,and a second jaw having a gripping surface. Each of the first and secondjaws may have a gripping pad having the gripping surface disposedthereon. Each jaw assembly is configured for being alternately closed togrip the elongated member between the respective gripping surfaces ofthe first and second jaws, and opened to release the elongated memberfrom between the respective gripping surfaces of the first and secondjaws.

The instrument driver further comprises three cam follower elementsoperably coupled to the respective jaw assemblies. Each of the camfollower elements includes a first groove, a second groove, and a firstbearing surface.

The instrument driver further comprises a cam shaft rotatably mounted tothe base. The cam shaft has three sets of cams respectively associatedwith the three cam follower elements. Each set of cams includes a linearcam and first and second oppositely pitched helical cams. The cam shaftis configured for being rotated relative to the base in a firstrotational direction in a manner that causes the three sets of cams torespectively actuate the three cam follower elements by, for each set ofcams and associated cam follower element, engaging the linear camagainst the first bearing surface, thereby translating the grippingsurface of the first jaw towards the gripping surface of the second jawto close the respective jaw assembly, engaging the first helical camwithin the first groove, thereby translating the respective jaw assemblyin a first axial direction when the respective jaw assembly is closed,and engaging the second helical cam within the second groove, therebytranslating the first jaw in a second axial direction opposite to thefirst axial direction when the respective jaw assembly is opened. Eachcam follower element may further have a second bearing surface, in whichcase, the cam shaft may be configured for being rotated in the firstrotational direction in a manner that, for each set of cams andassociated cam follower element, engages the linear cam against thesecond bearing surface, thereby translating the gripping surface of thefirst jaw away from the gripping surface of the second jaw to open therespective jaw assembly. The instrument driver may further comprise amotor configured for rotating the cam shaft relative to the base. Theinstrument driver may further comprise a housing containing the jawassemblies, the cam follower elements, and the cam shaft.

In one embodiment, at least one the jaw assemblies is always closed whenthe cam shaft is rotated, such that the elongated member is continuouslytranslated in the first axial direction during rotation of the camshaft. In another embodiment, the set of cams are clocked one hundredtwenty degrees from each other about the cam shaft. The cross-sectionsof the first and second grooves may be V-shaped, and the first bearingsurface and the second bearing surface may be circumferentially locatedon opposite sides of the cam shaft, and may have the samecircumferential orientation on the cam shaft.

The instrument driver may be for use with a telescoping assemblycomprising an outer elongated medical instrument and an inner elongatedmedical instrument. The outer medical instrument includes an outerelongated body and a proximal adapter affixed to the outer elongatedbody, and the inner medical instrument includes the aforementionedelongated member. In this case, the instrument driver comprises ahousing on which the base is mounted; and an interface mounted to thehousing and configured for being mated with the proximal adapter of theouter medical instrument. The inner elongated body is configured forbeing advanced within the outer elongated body when the jaw assembly istranslated in the first axial direction. The inner medical instrumentmay further have a proximal adapter affixed to the elongated member, inwhich case, the instrument driver further comprises a slidable carriageto which the proximal adapter of the inner medical instrument isconfigured for being mated, and at least one motor configured fortranslating the slidable carriage distally towards the sheath interfaceto translate the proximal catheter adapter towards the proximal sheathadapter while operating the cam shaft to translate the jaw assembly inthe first axial direction. The instrument driver may be a roboticinstrument driver incorporated into a medical system comprising a masterinput device configured for receiving commands from a user, and acomputer configured for controlling the robotic instrument driver inaccordance with the user commands.

In accordance with a fifth aspect of the present inventions, stillanother instrument driver for use with an elongated member (e.g., anelongated medical device, such as a steerable catheter and/or a balloonor stent delivery catheter). The instrument driver comprises a pair ofopposing rotatable gripping pads. Each of the rotatable gripping padsincludes an outer circular rim, a center hub, and a framework betweenthe outer circular rim and the hub. The opposing rotatable gripping padsare configured for applying a gripping force to the elongated member,and the frameworks of the respective rotatable gripping pads areconfigured for partially collapsing in response to the gripping force,such that portions of the rims of the respective rotatable gripping padsflatten to contact each other.

In one embodiment, each of the frameworks includes a plurality of spokesextending between the center hub and the outer circular rim of therespective rotatable gripping pad. The spokes may be curved, such thatthey collapse onto each other in response to the gripping force, therebyflattening the portions of the rims of the respective rotatable grippingpads. The spokes may have a thickness in the range of 0.010-0.050inches. The rim of each of the rotatable gripping pads may be composedof material having at least a 50 A durometer. Each of the rotatablegripping may have a diameter of two inches or less.

In one embodiment, the rim of each of the rotatable gripping pad has aconcave gripping surface in order to facilitate vertical centering ofthe elongated member between the rotatable gripping pads. In anotherembodiment, each of the rotatable gripping pads includes a pair ofopposing flat upper and lower surfaces, and a pair of upper and lowersprockets respectively disposed on the flat upper and lower surfaces. Inthis case, the upper and lower sprockets of one of the rotatablegripping pads are respectively configured for interlacing with the upperand lower sprockets of the other of the rotatable gripping pads toprevent the elongated member from slipping out between the rotatablegripping pad pads. One of the rotatable gripping pads may be configuredfor driving the other of the rotatable gripping pads via the interlacingof the upper and lower sprockets of the one rotatable gripping padrespectively with the upper and lower sprockets of the other rotatablegripping pad.

The instrument driver further comprises a pair of shafts affixed to thecenter hubs of the respective rotatable gripping pads, and a driverassembly configured for rotating at least one of the shafts, therebycausing the rotatable gripping pads to rotate in opposite directions tolinearly translate the gripped elongated member between the rotatablegripping pads. The driver assembly may further comprise a drive trainconfigured for being actuated to rotate at least one of the shafts, anda motor configured for actuating the drive train. In one optionalembodiment, the pair of opposable arms comprises a pair of loweropposable arms, the driver assembly includes a lower pair of opposablearms, and the shafts are configured for mating with correspondingapertures in the respective lower arms, such that the lower armsrespectively pivot with the upper arms in unison. The instrument drivermay further comprise a housing containing the driver assembly.

In one optional embodiment, the instrument further comprises a pair ofopposable arms on which the shafts are respectively rotatably disposed.One of the opposable arms may be configured for being pivoted in onedirection to grip the elongated member between the rotatable grippingpads, and pivoted in a second opposite direction to release theelongated member from between the rotatable gripping pads. The driverassembly may further include a gripping force adjustment mechanismconfigured for being actuated to alternately pivot the one arm in thefirst direction and in the second opposite direction. The gripping forceadjustment mechanism may include a compression spring configured forbeing varied to adjust the gripping force of the arms when gripping theelongated member. In this case, the gripping force adjustment mechanismmay further include a rod associated with the compression spring andmechanically coupled to one of the arms. The rod may be configured forbeing alternately actuated to pivot the one arm in the first directionand in the second opposite direction.

The instrument driver may be for use with a telescoping assemblycomprising an outer elongated medical instrument and an inner elongatedmedical instrument. The outer medical instrument includes an outerelongated body and a proximal adapter affixed to the outer elongatedbody, and the inner medical instrument includes the aforementionedelongated member. In this case, the instrument driver comprises ahousing on which the base is mounted; and an interface mounted to thehousing and configured for being mated with the proximal adapter of theouter medical instrument. The inner elongated body is configured forbeing advanced within the outer elongated body when the jaw assembly istranslated in the first axial direction. The inner medical instrumentmay further have a proximal adapter affixed to the elongated member, inwhich case, the instrument driver further comprises a slidable carriageto which the proximal adapter of the inner medical instrument isconfigured for being mated, and at least one motor configured fortranslating the slidable carriage distally towards the sheath interfaceto translate the proximal catheter adapter towards the proximal sheathadapter while operating the cam shaft to translate the jaw assembly inthe first axial direction. The instrument driver may be a roboticinstrument driver incorporated into a medical system comprising a masterinput device configured for receiving commands from a user, and acomputer configured for controlling the robotic instrument driver inaccordance with the user commands.

In accordance with a sixth aspect of the present inventions, yet anotherinstrument driver for use with an elongated member (e.g., an elongatedmedical device, such as a steerable catheter and/or a balloon or stentdelivery catheter). The instrument driver comprises a pair of rotatablegripping pads configured for being rotated in opposite directions whenthe elongated member is gripped therebetween, and a pair of opposablearms on which the rotatable gripping pads are respectively rotatablydisposed. The instrument driver may further comprise a gear assemblyconfigured for being actuated to rotate the rotatable gripping pads inthe opposite directions.

The instrument driver further comprises a first rod configured for beingtranslated in opposite directions along its longitudinal axis to pivotone of the arms in a first rotational direction, such that the elongatedmember can be gripped between the rotatable gripping pads, and to pivotthe one arm in a second rotational direction opposite to the firstrotational direction, such that the elongated member can be releasedfrom between the rotatable gripping pads. The instrument driver mayfurther comprise a motor configured for translating the first rod in theopposite directions along its longitudinal axis, and a housingcontaining the first rod, the spring, and the motor.

The instrument driver further comprises a compression spring associatedwith the first rod, wherein the compression of the spring is configuredfor being varied to adjust the translation of the first rod along thelongitudinal axis, thereby adjusting the gripping force of the arms whengripping the elongated member. The compression of the spring may beproportional to the gripping force of the arms when gripping theelongated member. In one embodiment, the instrument driver furthercomprises a second rod mounted to the one arm, and a lever arm mountedbetween the first rod and the second rod, such that translation of thefirst rod in the opposite directions along its longitudinal axis rotatesthe lever arm, thereby rotating the second rod about its longitudinalaxis to alternately pivot the one arm in the first and second rotationaldirections. Optionally, the instrument driver may further comprise apair of section gears respectively coupled to the arms. The sectiongears engage each other, such that the other one of the arms pivots in adirection opposite to the direction in which the one arm pivots.

In one embodiment, the instrument driver further comprises a lead screwconfigured for being rotated about its longitudinal axis to linearlydisplace the first rod in the opposite directions along its longitudinalaxis. In this case, the instrument driver may further comprise a leadnut having a first bore in which the lead screw is in threadedengagement, and a second bore in which the first rod is in bearingengagement, such that rotation of the lead screw about its longitudinalaxis in opposite rotational directions respectively displaces the leadnut in opposite longitudinal directions to linearly displace the firstrod respectively in the opposite directions along its longitudinal axis.The first rod may include a pair of annular flanges, in which case, thespring is disposed about the first rod between the annular flanges, andthe lead nut is disposed between the spring and one of the annularflanges.

In another embodiment, the pair of opposable arms comprises a pair oflower opposable arms, and the instrument driver further comprises a basemounted to the housing, an upper pair of opposable arms pivotablymounted to the base, and a pair of shafts on which the rotatablegripping pads are respectively mounted. The shafts are rotatably mountedto the respective upper arms, and configured for mating withcorresponding apertures in the respective lower arms, such that thelower arms respectively pivot with the upper arms pivot in unison.Optionally, one of the upper arms includes a bifurcated claw configuredfor vertically centered the elongated member between the rotatablegripping pads. The pair of lower arms may respectively include a pair ofcollars forming the corresponding apertures, and the instrument drivermay comprise a sterile drape surrounding the housing. In this case, thesterile drape includes a pair of plugs respectively mated with the pairof collars, and the pair of shafts are respectively mated with the pairof plugs. The sterile drape may be configured for folding or collapsingbetween the plugs when the one arm pivots the arms in the firstdirection, and unfolding or expanding between the plugs when the one armpivots the arms in the second direction. In this case, the sterile drapemay include an expansion joint that facilitates the folding orcollapsing of the sterile drape between the plugs, and that facilitatesthe unfolding or expansion of the sterile drape between the plugs.

The instrument driver may be for use with a telescoping assemblycomprising an outer elongated medical instrument and an inner elongatedmedical instrument. The outer medical instrument includes an outerelongated body and a proximal adapter affixed to the outer elongatedbody, and the inner medical instrument includes the aforementionedelongated member. In this case, the instrument driver comprises ahousing on which the base is mounted; and an interface mounted to thehousing and configured for being mated with the proximal adapter of theouter medical instrument. The inner elongated body is configured forbeing advanced within the outer elongated body when the jaw assembly istranslated in the first axial direction. The inner medical instrumentmay further have a proximal adapter affixed to the elongated member, inwhich case, the instrument driver further comprises a slidable carriageto which the proximal adapter of the inner medical instrument isconfigured for being mated, and at least one motor configured fortranslating the slidable carriage distally towards the sheath interfaceto translate the proximal catheter adapter towards the proximal sheathadapter while operating the cam shaft to translate the jaw assembly inthe first axial direction. The instrument driver may be a roboticinstrument driver incorporated into a medical system comprising a masterinput device configured for receiving commands from a user, and acomputer configured for controlling the robotic instrument driver inaccordance with the user commands.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of various embodiments ofthe present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is a perspective view of a prior art instrument driver for usewithin medical robotic system;

FIG. 2 is a perspective view of a medical robotic system constructed inaccordance with one embodiment of the present inventions;

FIG. 3 is a perspective view of a robotic catheter assembly used in themedical robotic system of FIG. 2;

FIG. 4 is a perspective view of the catheter assembly used in therobotic catheter assembly of FIG. 3;

FIG. 5 is a perspective view of an instrument driver used in the roboticcatheter assembly of FIG. 4;

FIG. 6 a perspective view of one embodiment of a catheter feeder thatcan be used in the instrument driver of FIG. 5;

FIG. 7 is a perspective view of the catheter feeder of FIG. 6, whereinthe housing has been removed;

FIG. 8 is a side view of the catheter feeder of FIG. 6, wherein thehousing has been removed;

FIG. 9 is a top perspective view of a jaw assembly arrangement and camassembly used in the catheter feeder of FIG. 6;

FIG. 10 is a bottom perspective view of the jaw assembly arrangement andcam assembly shown in FIG. 9;

FIG. 11 is a perspective view of the jaw assembly arrangement shown inFIG. 6;

FIG. 12 is a perspective view of a jaw assembly used in the jaw assemblyarrangement of FIG. 11;

FIG. 13 is top view of a jaw assembly used in the jaw assemblyarrangement of FIG. 11, particularly shown in a closed state;

FIG. 14 is top view of the jaw assembly of FIG. 13, particularly shownin an open state;

FIG. 15 is a perspective view of a driver assembly used in the catheterfeeder of FIG. 6;

FIG. 16 is a perspective view of a cam assembly used in the driverassembly of FIG. 15;

FIG. 17 is a perspective view of a cam follower element used in the camassembly of FIG. 16;

FIG. 18 is a top view of the cam follower element of FIG. 17;

FIG. 19 is a perspective view of a cam shaft used in the cam assembly ofFIG. 16;

FIG. 20 is a perspective view of a bearing assembly used in the driverassembly of FIG. 15;

FIG. 21 is another perspective view of a bearing assembly used in thedriver assembly of FIG. 15;

FIG. 22 is a perspective view of a portion of the driver assembly FIG.15, the jaw assembly arrangement FIG. 13, and a grip adjustment assemblyand loading/unloading assembly used in the catheter feeder of FIG. 6;

FIG. 23 is a perspective view of a portion of the driver assembly FIG.15, the jaw assembly arrangement FIG. 13, and a yoke used in the gripadjustment assembly of FIG. 23;

FIG. 24 is a perspective view of a drape used in the catheter feeder ofFIG. 6;

FIGS. 25a-25g are plan views illustrating an exemplary sequence used bythe catheter feeder of FIG. 6 to open, close, and translate one jawassembly of the jaw assembly arrangement FIG. 11 to advance/retract theleader catheter within the guide sheath of the catheter assembly of FIG.4;

FIGS. 26a-26d are plan views illustrating an exemplary sequence used bythe catheter feeder of FIG. 6 to open, close, and translate three jawassemblies of the jaw assembly arrangement FIG. 11 to advance/retractthe leader catheter within the guide sheath of the catheter assembly ofFIG. 4;

FIG. 27 a perspective view of another embodiment of a catheter feederthat can be used in the instrument driver of FIG. 5, particularlyshowing the catheter feeder in a closed position;

FIG. 28 a perspective view of the catheter feeder of FIG. 27,particularly showing the catheter feeder in an opened position;

FIG. 29 a top view of the catheter feeder of FIG. 27, particularlyshowing the catheter feeder in the closed position;

FIG. 30 a top view of the catheter feeder of FIG. 27, particularlyshowing the catheter feeder in the opened position;

FIG. 31 is a perspective view of a rotatable gripper assembly used inthe catheter feeder of FIG. 27, particularly showing the rotatablegripper assembly in a closed position;

FIG. 32 is a perspective view of the rotatable gripper assembly of FIG.31, particularly showing the rotatable gripper assembly in an openedposition;

FIG. 33 is a top view of a pair of rotatable gripping pads used in therotatable gripper assembly of FIG. 31, particularly showing the pair ofrotatable gripping pads in an opened position;

FIG. 34 is a side view of the pair of rotatable gripping pads of FIG.33, particularly showing the pair of rotatable gripping pads in theopened position;

FIG. 35 is a top view of the pair of rotatable gripping pads of FIG. 33,particularly showing the pair of rotatable gripping pads in a closedposition;

FIG. 36 is a side view of the pair of rotatable gripping pads of FIG.33, particularly showing the pair of rotatable gripping pads in theclosed position;

FIG. 37 is a perspective view of an optional pair of rotatable grippingpads used in the rotatable gripper assembly of FIG. 31, particularlyshowing the pair of rotatable gripping pads in a closed position;

FIG. 38 is a side view of the pair of rotatable gripping pads of FIG.37, particularly showing the pair of rotatable gripping pads in theclosed position;

FIG. 39 is a perspective view of a pair of lower arms of a driverassembly used in the catheter feeder of FIG. 27, particularly showingthe pair of lower arms in a closed position;

FIG. 40 is a perspective view of the pair of lower arms of FIG. 39,particularly showing the pair of lower arms in an opened position;

FIG. 41 is a perspective view of a drape used to mate the rotatablegripper assembly of FIG. 31 with a driver assembly used in the catheterfeeder of FIGS. 27-30;

FIG. 42 is a top view of a gear assembly used in the pair of lower armsof the driver assembly used in the catheter feeder of FIGS. 27-30,particularly showing the pair of lower arms in the closed position;

FIG. 43 is a top view of a gear assembly used in the pair of lower armsof the driver assembly used in the catheter feeder of FIGS. 27-30,particularly showing the pair of lower arms in the opened position;

FIG. 44 is a front view of the catheter feeder of FIGS. 27-30,particularly showing the catheter feeder in the closed position;

FIG. 45 is a front view of the catheter feeder of FIGS. 27-30,particularly showing the catheter feeder in the opened position;

FIG. 46 is a perspective view of a gripping force adjustment mechanismof the driver assembly used in the catheter feeder of FIGS. 27-30,particularly showing the state of the gripping force adjustmentmechanism when the catheter feeder is in the closed position;

FIG. 47 is a perspective view of the gripping force adjustment mechanismof FIG. 46, particularly showing the state of the gripping forceadjustment mechanism when the catheter feeder is in the opened position;

FIG. 48 is a top view of the gripping force adjustment mechanism of FIG.46, particularly showing the state of the gripping force adjustmentmechanism when the catheter feeder is in the closed position;

FIG. 49 is a top view of the gripping force adjustment mechanism of FIG.46, particularly showing the state of the gripping force adjustmentmechanism when the catheter feeder is in the opened position; and

FIG. 50 is a perspective view of the mating of the rotatable gripperassembly of FIG. 31 to the drape.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Referring to FIG. 2, one embodiment of a robotic catheter system 10constructed in accordance with the present invention will now bedescribed. The system 10 generally comprises an operating table 12having a movable support-arm assembly 14, an operator control station 16located remotely from the operating table 12, and a robotic catheterassembly 18 mounted to the support-arm assembly 14 above the operatingtable 12. Exemplary robotic catheter systems that may be modified forconstructing and using embodiments of the present invention aredisclosed in detail in the following U.S. patent applications, which areall expressly incorporated herein by reference in their entirety: U.S.patent application Ser. No. 11/678,001, filed Feb. 22, 2007; U.S. patentapplication Ser. No. 11/073,363, filed Mar. 4, 2005; U.S. patentapplication Ser. No. 11/179,007, filed Jul. 6, 2005; U.S. patentapplication Ser. No. 11/418,398, filed May 3, 2006; U.S. patentapplication Ser. No. 11/481,433, filed Jul. 3, 2006; U.S. patentapplication Ser. No. 11/637,951, filed Dec. 11, 2006; U.S. patentapplication Ser. No. 11/640,099, filed Dec. 14, 2006; U.S. PatentApplication Ser. No. 60/833,624, filed Jul. 26, 2006; and U.S. PatentApplication Ser. No. 60/835,592, filed Aug. 3, 2006.

The control station 16 comprises a master input device 20 that isoperatively connected to the robotic catheter assembly 18. A physicianor other user 22 may interact with the master input device 20 to operatethe robotic catheter assembly 18 in a master-slave arrangement. Themaster input device 20 is connected to the robotic catheter assembly 18via a cable 24 or the like, thereby providing one or more communicationlinks capable of transferring signals between the control station 16 andthe robotic catheter assembly 18. Alternatively, the master input device20 may be located in a geographically remote location and communicationis accomplished, at least in part, over a wide area network such as theInternet. The master input device 20 may also be connected to therobotic catheter assembly 18 via a local area network or even wirelessnetwork that is not located at a geographically remote location.

The control station 16 also comprises one or more monitors 26 used todisplay various aspects of the robotic instrument system 10. Forexample, an image of the guide sheath, leader catheter, and guidewire(described in further detail below) may be displayed in real time on themonitors 26 to provide the physician 22 with the current orientation ofthe various devices as they are positioned, for example, within a bodylumen or region of interest. The control station 16 further comprises aprocessor in the form of a computer 28, which may comprise a personalcomputer or other type of computer work station for accuratelycoordinating and controlling actuations of various motors within roboticcatheter assembly 18.

The support-arm assembly 14 is configured for movably supporting therobotic catheter assembly 18 above the operating table 12 to provideconvenient access to the desired portions of the patient (not shown) andprovide a means to lock the catheter assembly 18 into positionsubsequent to the preferred placement. In this embodiment, thesupport-arm assembly 14 comprises a series of rigid links 30 coupled byelectronically braked joints 32, which prevent joint motion whenunpowered, and allow joint motion when energized by the control station16. In an alternative embodiment, the rigid links 30 may be coupled bymore conventional mechanically lockable joints, which may be locked andunlocked manually using, for example, locking pins, screws, or clamps.The rigid links 30 preferably comprise a light but strong material, suchas high-gage aluminum, shaped to withstand the stresses and strainsassociated with precisely maintaining three-dimensional position of theweight of the catheter assembly 18.

Referring further to FIGS. 3 and 4, the robotic catheter assembly 18will now be described in detail. The robotic catheter assembly 18comprises a robotic instrument driver 34, a robotic guide sheath 36, arobotic leader catheter 38, and a conventional guidewire 40 mounted tothe instrument driver 34 in a coaxial and telescoping relationship. Therobotic catheter assembly 18 may also include a drape (not shown) thatcovers the non-disposable portion of the instrument driver 34. As willbe described in further detail below, the instrument driver 34 providesrobotic steering and advancement/retraction actuation to the guidesheath 36 and leader catheter 38, and robotic advancement/retraction androll actuation to the guidewire 40, in accordance with control signalstransmitted from the control station 16 (shown in FIG. 2). The guidesheath 36 generally includes a sheath body 42 having a proximal end 44and a distal end 46, as well as a proximal interface in the form of aguide sheath steering adapter 48 (“splayer”) operably coupled to theproximal end 44 of the sheath body 42. The leader catheter 38 generallyincludes a catheter body 50 having a proximal end 52 and a distal end54, as well as a proximal interface in the form of a leader cathetersteering adapter 56 (“splayer”) operably mounted to the proximal end 52of the catheter body 50. In an alternative embodiment, rather than aleader catheter 38, a microcatheter (not shown) may be used instead. Theguidewire 40 generally includes a guidewire body 58 having a proximalend 60 and a distal end 62. The proximal sheath adapter 48 mayoptionally comprises an active valve 64 for providing a means forpurging the working lumen of the guide sheath 36.

Each of the adapters 48, 56 also comprises one or more drive shafts 66with corresponding spools or drums (not shown) that can selectivelytension or release pullwires (not shown) disposed within the respectivesheath body 42 and catheter body 50, thereby effecting a singlearticulation (and optionally, multiple articulations) of the distal ends46, 54 of the sheath and catheter bodies 42, 50. In the illustratedembodiment, each of the adapters 48, 56 comprises four rotating driveshafts 66 (only one shown for the proximal sheath adapter 48, and onlythree shown for the proximal adapter 56) for four correspondingpullwires. In this case, the distal ends 46, 54 of the sheath andcatheter bodies 42, 50 may be articulated in an infinite amount ofdirections. In the case where a microcatheter is used in place of theleader catheter 38, it may include a proximal adapter capable ofinserting, retracting and rolling its distal end.

The guide sheath 36 comprises a working lumen (not shown) that extendsall the way through the sheath body 42. The geometry and size of theworking lumen will be selected in accordance with the cross-sectionalgeometry and size of the lead catheter 38. The sheath body 42 may becomposed of a low-friction inner layer (e.g., a coating of silicone orpolytetrafluoroethylene) to provide a low-friction surface toaccommodate movement of the leader catheter 38 within the working lumen.The leader catheter 38 passes through the lumen of the guide sheath 36,and is thus, moveable relative thereto. As shown in FIGS. 3 and 4, theleader catheter 38 projects distally with respect to the distal end 46of the sheath body 42. Of course, the leader catheter 38 may bewithdrawn proximally such that its distal end 54 is substantially flushwith the distal end 46 of the sheath body 42, or withdrawn proximallyeven further such that its distal end 54 is disposed within the distalend 46 of the sheath body 42. The leader catheter 38 may be movablypositioned within the working lumen of the guide sheath 36 to enablerelative advancement/retraction of the leader catheter 38 within theguide sheath 36, and relative steering or bending of the two devicesrelative to each other, particularly when the distal end 54 of theleader catheter 38 is advanced beyond the distal tip of the guide sheath36.

Similarly, the leader catheter 38 comprises a working lumen (not shown)that extends at least partially through the catheter body 50. Thegeometry and size of the working lumen will be selected in accordancewith the cross-sectional geometry and size of the guidewire 40. Thecatheter body 50 may be composed of a low-friction inner layer (e.g., acoating of silicone or polytetrafluoroethylene) to provide alow-friction surface to accommodate movement of the guidewire 40 withinthe working lumen. The guidewire 40 passes through the lumen of theleader catheter 38, and is thus, moveable relative thereto. As shown inFIGS. 3 and 4, the guidewire 40 projects distally with respect to thedistal end 54 of the catheter body 50. Of course, the guidewire 40 maybe withdrawn proximally such that its distal end 62 is substantiallyflush with the distal end 54 of the catheter body 50, or withdrawnproximally even further such that its distal end 62 is disposed withinthe distal end 54 of the catheter body 50. The guidewire 40 may bemovably positioned within the working lumen of the leader catheter 38 toenable advancement/retraction and rotation or “roll” of the guidewire 40within the leader catheter 38. Notably, by movably positioning theguidewire 40 relative to the leader catheter 38, and movably positioningthe leader catheter 38 relative to the guide sheath 36, the bendingstiffness of the assembly may be varied as needed to optimize thetracking ability of the leader catheter 38.

The instrument driver 34 comprises a housing 68 that contains motors anddrive mechanisms (not shown in FIGS. 3 and 4). The respective adapters48, 56 are mechanically interfaced to the housing 68 in such a mannerthat they may be axially translated relative to each other via operationof the motors, thereby effecting advancement or retraction movements ofthe respective guide sheath 36 and leader catheter 38 relative to eachother, and thus, relative to the operating table 12 (shown in FIG. 2).In particular, the respective proximal adapters 48, 56 are removablymounted to respective mounting plates 70, 72, which in turn, arerespectively affixed to an interface in the form of a sheath drive block74 and a catheter carriage 76. In the illustrated embodiment, theproximal adapters 48, 56 are disposable units, and thus, can be locatedon a similarly disposable sterile adapter (not shown) into which themounting plates 70, 72 are built. The sterile adapter can be disposedover the sterile drape of the housing 68, and once the medical procedureis completed, removed along with the other disposable units from thesterile housing 68. Each of the mounting plates 70, 72 includes fouropenings 78 for receiving the four corresponding drive shafts 66 of therespective proximal adapters 48, 56. The drive shafts 66 are coupled todrive assemblies (not shown) contained within the housing 68 forselectively rotating the drive shafts 66, and thereby, selectivelytensioning the corresponding pull wires to articulate the distal ends46, 54 of the sheath and catheter bodies 42, 50.

The instrument driver 34 may include a lead screw mechanism (not shown)coupled between one of the motors and the catheter carriage 76 fordriving the carriage 76 distally and proximally to perform theinsertion/retraction actuations of the leader catheter 38. The entirerobotic catheter assembly 18 can be moved relative to the support-armassembly 14 to provide insertion/retraction actuation for the guidesheath 36. In an alternative embodiment, the proximal sheath adapter 48of the guide sheath 36 is mounted to a sheath carriage (not shown) viamounting plate 70. In this case, the instrument driver 34 may includetwo independently-actuated lead screw mechanisms (not shown)respectively coupled between motors contained in the housing 68 and thecarriages for independently driving the carriages distally andproximally to perform the insertion/retraction actuations of the guidesheath 36 and leader catheter 38.

Significantly, the instrument driver 34 comprises an active catheterfeeder 80 that actively advances the leader catheter 38 within the guidesheath 36 and actively retracts the leader catheter 38 within the guidesheath 36 in coordination with the translation of the catheter carriage76. That is, during a robotic advancement/retraction action of theleader catheter 38, the active catheter feeder 80 simultaneouslyadvances the leader catheter 38 into the guide sheath 36 at the samespeed at which the catheter carriage 76 is translated towards the sheathdrive block 74, thereby preventing the axial buckling of the leadercatheter 38 between the sheath drive block 74 and catheter carriage 76,and simultaneously retracts the leader catheter 38 within the guidesheath 36 at the same speed at which the catheter carriage 76 istranslated away from the sheath drive block 74. Alternatively, if theleader catheter 38 is longer than the guide sheath 36 by a distance thatis greater than the maximum distance between the sheath drive block 74and the catheter carriage 76, the active catheter feeder 80 may advancethe leader catheter 38 at a higher speed than the catheter carriage 76moves, thereby allowing the leader catheter 38 to be inserted furtherthan what is achievable without the active catheter feeder 80.

To maximize its non-buckling effect, the active catheter feeder 80preferably resides as close as possible to the proximal sheath adapter48 where the leader catheter 38 enters the guide sheath 36. In thealternative case where the proximal sheath adapter 48 is mounted to aseparate carriage, the active catheter feeder 80 is preferably mountedto this carriage, such that it moves with the proximal sheath adapter 48in order to maintain the close proximity between the active catheterfeeder 80 and the proximal sheath adapter 48. Thus, in both cases, theactive catheter feeder 80 is affixed relative to the sheath interface(sheath drive block 74 or sheath carriage). The external portion of theactive catheter feeder 80, as a disposable unit, can all be convenientlylocated on the mounting plate 70 on which the proximal adapter 48 islocated. The catheter feeder 80 may be self-contained or may beintegrated into the housing 68 of the instrument driver 34.

To maximize the range of the translation of the catheter carriage 76(the “stroke”) toward the sheath drive block 74, the length of theactive catheter feeder 80 is minimized (e.g., less than 6 inches). It isalso preferable that the active catheter feeder 80 apply pressure to theleader catheter 38 in a manner that firmly grips the leader catheter 38in a manner that prevents slippage of the leader catheter 38 (even ifthe leader catheter 38 is hydrophilic and wet), without pinching theleader catheter 38 in a manner that might otherwise collapse the lumenof the leader catheter 38 and prevent or hinder movement of theguidewire 40 within the leader catheter 38, or in the case where workingcatheters, such as stent/balloon catheters, are activelyadvanced/retracted within the guide sheath 36, minimally affects theinjection during deployment of the stent or balloon. The active catheterfeeder 80 preferably retains this capability for a range of catheterdiameters. For example, the active catheter feeder 80 should be operablewith a 6 F leader catheter, but also microcatheter in the range of 2.5-3F or bigger catheters up to 12 Fr.

The active catheter feeder 80 preferably allows top loading of theleader catheter 38 to provide an efficient and quick means of installingthe leader catheter 38 onto the instrument driver 34. The activecatheter feeder 80 also preferably provides for infiniteadvancement/retraction range of actuation; that is, the active catheterfeeder 80 is capable of continually advancing/retracting an infinitelength of the leader catheter 38. In such cases, the active catheterfeeder 80 feeds the leader catheter 38 at a much higher rate of motionthan the catheter carriage 76 advancement. The exact relationshipbetween how much the leader catheter 38 is advanced into the guidesheath 74 by the active catheter feeder 80 and how much the cathetercarriage 76 moves can be adjusted and controlled for each catheter typeand length.

The instrument driver 34 further comprises a guidewire feeder 82 mountedto the catheter carriage 76 and to which the proximal end 60 of theguidewire body 58 is affixed. The distal end 62 of the guidewire body 58may have a J-shape or may be straight as is conventional for guidewires.Each of the adapters 48, 56 and guidewire driver 68 may optionally becapable of rotating or rolling the sheath body 42, catheter body 50, andguidewire body 58 relative to each other.

Referring to FIG. 6-26, one embodiment of an active catheter feeder 100will now be described. The catheter feeder 100 is designed to mimic themanual finger feed method that physicians may use to advance/retract theleader catheter 38 within the guide sheath 36, and in particular, thegrip, push, release, retracting, and repeating movements performed bythe fingers of the physician to incrementally advance the leadercatheter 38, and the grip, pull, release, advancing, and repeatingmovements performed by the fingers of the physician to incrementallyretract the leader catheter 38. In the illustrated embodiment, thecatheter feeder 100 is mounted to the outside of the housing 68 betweenthe sheath drive block 74 and the catheter carriage 76.

To this end, and with particular reference to FIGS. 6-8, the catheterfeeder 100 generally comprises a feeder assembly 102 configured foradvancing/retracting the leader catheter 38 within the guide sheath 36,a grip adjustment assembly 104 configured for adjusting the grip of thefeeder assembly 102, a loading/unloading assembly 105 configured forallowing the leader catheter 38 to be top-loaded and unloaded from theactive catheter feeder 100, a base plate 106 on which the feederassembly 102 and grip adjustment assembly 104 are mounted, a housing 108mounted to the base plate 106 over the feeder assembly 102 and gripadjustment assembly 104, and a drape 110 configured for isolating thedisposable components of the catheter feeder 100 from the sterile field.

The feeder assembly 102 generally comprises a jaw assembly arrangement112 configured for performing advancing/retracting movements of theleader catheter 38, and a driver assembly 114 configured for actuatingthe jaw assembly arrangement 112 to perform these movements.

Referring further to FIGS. 9-11, the jaw assembly arrangement 112includes three jaw assemblies 120 a, 120 b, 120 c configured for beingindependently translated relative to the base plate 106 parallel to alongitudinal axis 116 in a reciprocal manner. To this end, the jawassemblies 120 respectively include base plates 122 that are slidablyengaged with each other in a nested arrangement. In order to guideindependent translation of the jaw assemblies 120 along the longitudinalaxis 116, the jaw assembly arrangement 112 further includes a parallelpair of rails 124 mounted to the base plate 106 along the longitudinalaxis 116, and each jaw assembly 112 includes a pair of channeled blocks126 mounted to the respective base plate 122 for slidably receiving thepair of rails 124 therein, as best shown in FIG. 10.

Referring specifically to FIGS. 12-14, each jaw assembly 120 comprises afirst jaw 128 having a jaw actuator 132 (not shown in FIG. 12), agripping flange 136 affixed to the jaw actuator 132, and a gripping pad140 (shown in phantom in FIG. 12) mounted to the gripping flange 136,and a second jaw 130 having a jaw actuator 134 (not shown in FIG. 12), agripping flange 138 affixed to the jaw actuator 134, and a gripping pad142 (shown in phantom in FIG. 12) mounted to the gripping flange 138.The jaw assembly 120 is configured for being alternately closed (FIG.13) to grip the catheter body 50 between the respective gripping pads140, 142 of the first and second jaws 128, 130, and opened (FIG. 14) torelease the catheter body 50 from between the respective gripping pads140, 142 of the first and second jaws 128, 130. For the purposes of thisspecification, a jaw assembly is closed at the point where the grippingpads 140, 142 are closest to each other, and is open at the point wherethe gripping pads 140, 142 are furthest from each other (after thesecond jaws 130 are adjusted to a fixed position by the grip adjustmentassembly 104, as will be described in further detail below). The jawassembly 120 is designed in a manner that the catheter body 50 is onlygripped when the jaw assembly 120 is in the closed position, and thecatheter body 50 is released when the jaw assembly 120 is in the openedposition or transitioning between the closed position and the openedposition.

Notably, the gripping pads 140, 142 inherently have gripping surfacesthat distribute the gripping force applied to the catheter body 50,thereby preventing pinching. As such, a relatively large gripping forcecan be applied to the catheter body 50 to prevent slippage, as well asto compensate for varying catheter diameters. Furthermore, as will bediscussed in further detail below, the grip adjustment assembly 104 canbe operated to adjust the strength that the jaw assembly 104 grips thecatheter body 50 between the gripping pads 140, 142.

The major surfaces of the gripping flanges 136, 138 of the first andsecond jaws 128, 130, and thus the gripping pads 140, 142, are parallelto the longitudinal axis 116, whereas the major surfaces of the jawactuators 132, 134 slide relative to each other along a transverse axis118 perpendicular to the longitudinal axis 116 to facilitate placementof the jaw assembly 120 between the closed and opened positions. In theillustrated embodiment, while the second jaw 130 remains fixed, thefirst jaw 128 translates toward the second jaw 130, thereby translatingthe gripping pad 140 toward the stationary gripping pad 142 to place thejaw assembly 120 in the closed position, and translates away from thesecond jaw 130, thereby translating the gripping pad 140 away from thestationary gripping pad 142 to place the jaw assembly 120 in the openposition.

In order to guide the translation of the first jaw 128 along thetransverse axis 118, the jaw assembly 120 further includes a rail 144mounted to the base plate 122 of the respective jaw assembly 120 alongthe transverse axis 118, and the jaw assembly 120 includes a channeledblock 146 mounted to the jaw actuator 132 of the first jaw 128 forslidably receiving the rail 144 therein, as best shown in FIG. 12 (jawactuator 132 not shown). As will be described in further detail below,the second jaws 130 of the three jaw assemblies 120 a, 120 b, 120 c maybe translated in unison along the transverse axis 118 via operation ofthe grip adjustment assembly 104. In order to guide the translation ofthe second jaw 130 of each jaw assembly 120 along the transverse axis118, the rail 144 extends the length of the respective base plate 122,and the respective jaw assembly 120 includes another channeled block 148mounted to the jaw actuator 134 of the second jaw 130 for slidablyreceiving the rail 144 therein, as best shown in FIG. 12 (jaw actuator134 not shown).

Referring now to FIGS. 9, 10, and 15, the driver assembly 114 generallycomprises a cam assembly 150 configured for actuating the respective jawassemblies 120, a motor assembly 152, and a drive train 154 operablycoupled between the motor assembly 152 and the cam assembly 150.

The cam assembly 150 is configured for translating the jaw assemblies120 along the longitudinal axis 116, and opening and closing therespective jaw assemblies 120, in a manner that continuallyadvances/retracts the leader catheter 38 within the guide sheath 36. Tothis end, the cam assembly 150 generally comprises three cam followerelements 156 a, 156 b, 156 c respectively associated with the three jawassemblies 120 a, 120 b, 120 c, a cam shaft 158 disposed through the camfollower elements 156, and a pair of bearing supports 160 in which thecam shaft 158 is rotatably mounted.

Each of the bearing supports 160 includes a bearing aperture 162 and abearing ring 164 disposed within the respective bearing aperture 162.The opposing ends of the cam shaft 158 are respectively mounted throughthe bearing rings 164 of the respective bearing supports 160, such thatthe cam shaft 158 may rotate about a longitudinal axis extending throughthe centers of the bearing apertures 162. The bearing supports 160 aremounted to the base plate 106 in a manner that orients the cam shaft 162along the longitudinal axis 116.

As best shown in FIG. 9, the jaw actuators 132 of the jaw assemblies 120a, 120 b, 120 c (only jaw assembly 120 a shown in FIG. 9) arerespectively mounted to the cam follower elements 156 a, 156 b, 156 c,such that reciprocal translation of each of the cam follower elements156 along the longitudinal axis 116 will reciprocally translate theassociated jaw assembly 120 along the longitudinal axis 116, andreciprocal translation of each of the cam follower elements 156 a, 156b, 156 c along the transverse axis 118 will reciprocally open or closethe associated jaw assembly 120 by translating the first jaw 126 towardor away from the second jaw 126.

That is, translation of a cam follower element 156 along thelongitudinal axis 116 correspondingly displaces the jaw actuator 132 ofthe associated jaw assembly 120 along the longitudinal axis 116. As aresult, the channeled block 146 mounted to the jaw actuator 132 bearsperpendicularly against the rail 144 mounted to the base plate 122 ofthe associated jaw assembly 120 (shown in FIG. 12), thereby translatingthe associated jaw assembly 120 along the longitudinal axis 116, whichis guided by sliding engagement between the pair of channeled block 126mounted to the base plate 122 of the associated jaw assembly 120 withthe pair of rails 124 mounted to the base plate 106. Translation of thecam follower element 156 along the transverse axis 118 correspondinglydisplaces the jaw actuator 132 of the associated jaw assembly 120 alongthe transverse axis 118. As a result, the first jaw 126 to which the jawactuator 132 is mounted is translated along the longitudinal axis 116toward or away from the second jaw 126, which is guided by slidingengagement between the channeled block 146 mounted to the jaw actuator132 with the rail 144 mounted to the base plate 122, to close or openthe associated jaw assembly 120 (shown in FIGS. 13 and 14). The camfollower elements 156 are preferably spaced at least a small distancefrom the base plate 106 to allow the cam follower elements 156 to freelytranslate without friction.

The cam follower elements 156 and cam shaft 158 include cam featuresthat, when the cam shaft 158 is rotated in a first rotational direction,advances the leader catheter 38 within the guide sheath 36, and when thecam shaft 158 is rotated in a second opposite rotational direction,retracts the leader catheter 38 within the guide sheath 36. Inparticular, rotation of the cam shaft 158 in either rotational directionaxially translates each jaw assembly 120 along the longitudinal axis ofthe cam shaft 158 (i.e., along the longitudinal axis 116) via the jawactuator 132 in a reciprocating manner, and further closes and openseach jaw assembly 120 via the jaw actuator 132 in a reciprocatingmanner. The reciprocating motions of the axial translation andopening/closing of each jaw assembly 120 are timed relative to eachother.

In particular, as shown in FIG. 9, rotation of the cam shaft 158 in afirst rotational direction 166 closes the jaw assembly 120 when the jawassembly 120 is linearly translated in a first axial direction 170(front stroke), and opens the jaw assembly 120 when the jaw assembly 120is linearly translated in a second opposite axial direction 172 (rearstroke). Rotation of the cam shaft 158 in a second opposite rotationaldirection 168 opens the jaw assembly 120 when the jaw assembly 120 islinearly translated in the first axial direction 170 (rear stroke), andcloses the jaw assembly 120 when the jaw assembly 120 is linearlytranslated in the second axial direction 172 (front stroke).Significantly, the reciprocating motion of each jaw assembly 120provides for infinite advancement/retraction range of actuation for theleader catheter 38.

To this end, and with further reference to FIGS. 16-19, the three camfollower elements 156 a, 156 b, 156 c are identical in nature, each ofwhich includes a bottom block portion 174 having a recess 176 forreceiving the bottom portion of the cam shaft 158, and a top blockportion 178 having a set of cam features that interact with associatedcam features on the cam shaft 158, as described below. The cam shaft 158includes three sets of cam features 180 a, 180 b, 180 c thatrespectively interact the cam features of the three cam followerelements 156 a, 156 b, 156 c to actuate the three associated jawassemblies 120 a, 120 b, 120 c.

For purposes of brevity and clarity, the structure and function of thecam features of only one of the cam follower elements 156 and associatedjaw assembly 120 with a corresponding set of cam features on cam shaft158 will now be described.

The reciprocating axial motion of the jaw assembly 120 is controlled bytwo opposing partial worm thread features. In particular, the camfollower element 156 includes a first groove 182 and a second groove184, and the cam shaft 158 includes a first helical cam 186 and a secondhelical cam 188 that are oppositely pitched (or angled) relative to eachother. In the illustrated embodiment, the first and second grooves 182,184 are arranged adjacent opposite sides of the cam shaft 158, and thefirst and second helical cams 186, 188 have the same circumferentialorientation on the cam shaft 158. In this case, the first and secondhelical cams 154 are essentially mirrors of each other.

The first helical cam 186 and second helical cam 188 respectively drivethe cam follower element 156 and associated jaw assembly 120 in oppositeaxial directions. In particular, the first helical cam 186 is capable ofbeing engaged within the first groove 182 as the cam shaft 158 rotatesduring a portion of a complete rotation, thereby translating the camfollower element 156, and thus the jaw assembly 120, in one of the axialdirections 170, 172 a predetermined maximum distance (the first axialdirection 170 if the cam shaft 158 is rotated in the first rotationaldirection 166, and the second axial direction 172 if the cam shaft 158is rotated in the second rotational direction 168), and the secondhelical cam 188 is capable of being engaged within the second groove 184as the cam shaft 158 rotates during another portion of a completerotation, thereby translating the cam follower element 156, and thus thejaw assembly 120, in the other of the axial directions 170, 172 apredetermined maximum distance (the second axial direction 172 if thecam shaft 158 is rotated in the first rotational direction 166, and thefirst axial direction 170 if the cam shaft 158 is rotated in the secondrotational direction 168).

The circumferential lengths of the grooves 182, 184 and helical cams186, 188 are such that at least one of the helical cams 186, 188 isalways received within the respective grooves 182, 184 in order tocontinuously maintain control of the axial translation of the jawassembly 120 and to ensure that each of the helical cams 186, 188 isproperly aligned as it enters the respective groove 182, 184. That is,as long as one of the helical cams 186, 188 is received within itsrespective groove 182, 184, the other of the helical cams 186, 188 willbe aligned as it enters its respective groove 182, 184. The grooves 182,184 are axially offset from each other in a manner that aligns thehelical cams 186, 188 with the respective grooves 182, 184.

The combined length of the first helical cam 186 and first groove 182 isequal to the combined length of the second helical cam 188 and secondgroove 184, so that the predetermined distance which the jaw assembly120 translates in the first axial direction 144 equals the predetermineddistance which the jaw assembly 120 translates in the second axialdirection 170 (i.e., axial reciprocation of the jaw assembly 120 issymmetrical). This predetermined maximum distance can be considered thestroke length of the catheter feeder 100. The axial stroke length of thecatheter feeder 100 may be adjusted by changing the pitch of the helicalcams 186, 188. In particular, the axial stroke length can be increasedby accordingly increasing the pitch of the helical cams 186, 188,whereas the stroke length can be decreased by accordingly decreasing thepitch of the helical cams 186, 188. The axial stroke length selected isdependent on the buckling strength of the leader catheter 76 and theforce required to insert it into the guide sheath 74. For example, alarger pitch will provide a greater axial stroke length, but it must beensured that the flexible leader catheter 76 can resist the insertionload over this distance without buckling. Softer, more flexible leadercatheters 76 will require smaller pitches because they will have lowerbuckling resistance, thereby requiring shorter axial stroke lengths. Itshould be appreciated that adjusting the pitch of the helical cams 186,188 does not decrease their strength in contrast to spur gear designswhere the gear tooth size/strength is directly related to teeth spacingand gear diameter adjustable to change the stroke length.

Although it is possible for there to be a relatively short time duringwhich both helical cams 186, 188 are received within the respectivegrooves 182, 184, it is important that both helical cams 186, 188 notactually be engaged within the respective grooves 182, 184 to preventthe conflict between opposite axial translations of the jaw assembly120. To this end, the grooves 182, 184 have a V-shaped cross-section,and the tips of the helical cams 186, 188 are chamfered. In this manner,the helical cams 186, 188 can be respectively received within thegrooves 182, 184 prior to engagement of the helical cams 186, 188 withthe respective grooves 182, 184. Thus, as one of the helical cams 186,188 disengages with its respective corresponding groove 182, 184, theother of the helical cams 186, 188 engages its respective correspondinggroove 182, 184.

The reciprocating opening/closing motion of the jaw assembly 120 iscontrolled by a short lift duration cam feature. In particular, the camfollower element 156 further includes a first bearing surface 190 and asecond bearing surface 192, and the cam shaft 158 includes a linear cam194. The linear cam 194 is capable of engaging the first bearing surface190 as the cam shaft 158 rotates during a portion of a completerotation, thereby translating the cam follower element 156, and thus thegripping pad 140 of the first jaw 128, towards the gripping pad 142 ofthe second jaw 130 to close the jaw assembly 120, and engaging thesecond bearing surface 192 as the cam shaft 158 rotates during anotherportion of the complete rotation, thereby translating the cam followerelement 156, and thus the gripping pad 140 of the first jaw 128, awayfrom the gripping pad 142 of the second jaw 130 to open the jaw assembly120.

In the illustrated embodiment, the first and second bearing surfaces190, 192 are arranged adjacent opposite sides of the cam shaft 158, andthe linear cam 194 is circumferentially located adjacent the tips of thefirst and second helical cams 186, 188. In the illustrated embodiment,the linear cam 194 is also axially centered between the first and secondhelical cams 186, 188, and preferably does not axially extend outsidethe first and second helical cams 186, 188, thereby minimizing thelength of the catheter feeder 100. Alternatively, although the helicalcams 186, 188 and linear cam 194 are preferably located near each otherto provide for a more compact package, these cam features may beseparated by any distance along the cam shaft 158.

The ends of the linear cam 194 are chamfered in order to transitionengagement of the linear cam 194 with the bearing surfaces 190, 192,resulting in a gradual closing and opening of the jaw assembly 120.Because the jaw assembly 120 is only considered to be closed when thegripping pads 140, 142 of the respective jaws 128, 130 are the closestto each other, the jaw assembly 120 is considered to be closed when theunchamfered portion of the linear cam 194 are in engagement with thefirst bearing surface 190, and considered to be opened when theunchamfered portion of the linear cam 194 are in engagement with thesecond bearing surface 192. The jaw assembly 120 is considered to betransitioning from the opened position to the close position when thechamfered ends of the linear cam 194 are engaged with the first bearingsurface 192, and considered to be transitioning from the closed positionto the opened position when the chamfered ends of the linear cam 194 areengaged with the second bearing surface 192.

To maximize stroke efficiency, the dimensions and arrangement of the camfeatures are such that the jaw assembly 120 is closed at least most ofthe time in which it is linearly translated in the first axial direction170 when the cam shaft 158 is rotated in the first rotational direction166, and closed at least most of the time in which it is linearlytranslated in the second axial direction 172 when the cam shaft 158 isrotated in the second rotational direction 166. In other words, it ispreferred that the jaw assembly 120 grip the catheter body 50 duringmost of its front stroke (i.e., the linear stroke intended toadvance/retract the leader catheter 38). However, to ensure that thecatheter body 50 is not gripped during the rear stroke (i.e., the linearstroke intended to not advance/retract the leader catheter 38), the jawassembly 120 is preferably open for a short time at the beginning andend of the front stroke. To this end, the jaw assembly 120 completestransitions from the opened position to the closed position just afterinitiation of the front stroke, and begins to transition from the closedposition to the opened position just prior to termination of the frontstroke. Thus, the catheter body 50 will be gripped just after the frontstroke is initiated, and released just before the forward is stroke isterminated.

It should be appreciated that all three jaw assemblies 120 a, 120 b, 120c can be driven in the axial directions in the same manner that therepresentative jaw assembly 120 described above is driven in the axialdirections, and can be opened and closed in the same manner that therepresentative jaw assembly 120 described above is opened and closed.Preferably, the jaw assemblies 120 are actuated in a sequential mannerthat ensures that at least one jaw assembly is always closed when thecam shaft 158 is rotated, such that the leader catheter 38 is axiallytranslated in a continuous manner during rotation of the cam shaft 158.In the illustrated embodiment, to ensure that the catheter body 50 iscontinuously gripped, there may be a small amount of overlap between thefront strokes of two of the jaw assemblies 120, such that there is abrief period in which two of the jaw assemblies 120 are closed andgripping the catheter body 50.

This can be accomplished by clocking the three sets of cam features 180a, 180 b, 180 c on the cam shaft 158 one hundred twenty degrees fromeach other about the cam shaft 158, which sequentially actuates the jawassemblies 120 a, 120 b, 120 c (i.e., after the first jaw assembly 120 acloses, the second jaw assembly 120 b closes, and then the third jawassembly 120 c closes, and after the first jaw assembly 120 a opens, thesecond jaw assembly 120 b opens, and then the third jaw assembly 120 copens).

Referring back to FIG. 15, the motor assembly 152 comprises a motor 149,a motor mount 151 in which the motor 149 is mounted, and an electricalconnector 153 configured for coupling the cable 24 to the electronicswithin the motor 149, thereby allowing the motor 149 to be controlledvia the control station 16. The drive train 154 comprises a drive pulley196 mounted to the drive shaft (not shown) of the motor 149, anintermediary driven shaft 198 engaged with the drive pulley 196, a pairof driven spur gears 200 engaged with the driven shaft 198, and a pairof spur gears 202 affixed to the cam shaft 158 and engaged with thedriven spur gears 200.

To this end, the intermediary driven shaft 198 includes a driven pulley204 mechanically coupled to the drive pulley 196 via a drive belt (notshown). In the illustrated embodiment, each of the drive and drivenpulleys 196, 204 takes the form of a spur gear, in which case, the drivebelt is cogged. The intermediary driven shaft 198 further includes anelongated spur gear 206 that meshes with the pair of spur gears 200,which in turn mesh with the respective pair of spur gears 202 affixed tothe cam shaft 158. Thus, the motor 149 can be operated to rotate thedrive pulley 196 in the rotational direction 166, which rotates theintermediary driven shaft 198 in the same rotational direction 166,which in turn, rotates the driven spur gears 200 in the oppositerotational direction 168, which in turn, rotates the cam shaft 158 backto the rotational direction 166. Of course, the motor 149 can also beoperated to rotate the drive pulley 196 in the rotational direction 168,which rotates the intermediary driven shaft 198 in the same rotationaldirection 168, which in turn, rotates the driven spur gears 200 in theopposite rotational direction 166, which in turn, rotates the cam shaft158 back to the rotational direction 168.

The drive train 154 further comprises a pair of bearing supports 208(shown in phantom in FIG. 15) in which the intermediary driven shaft 198and spur gears 200 are rotatably mounted. In particular, as shown inFIGS. 20 and 21 (the bearing supports 208 shown partially in phantom),each of the bearing supports 208 includes a bearing aperture 210 and abearing ring 212 disposed within the respective bearing aperture 210.The driven shaft 198 is mounted through the bearing rings 212 of therespective bearing supports 208, such that the driven shaft 198 mayrotate about a longitudinal axis extending through the centers of thebearing apertures 210. The bearing supports 208 are mounted to the baseplate 106 in a manner that orients the driven shaft 198 parallel to thelongitudinal axis 116. Each of the bearing supports 208 further includesanother bearing aperture 214 in which a respective one of the spur gears200 is disposed, and a bearing boss (not shown) centered within thebearing aperture 214 and received within a center hole 218 in therespective spur gear 200. Each of the bearing supports 208 lastlyincludes an aperture 218 in which a respective one of the spur gears 202of the cam shaft 158 freely rotates.

It can be appreciated that the use of worm thread design in the catheterfeeder 100 provides robust contact with the reciprocating components,and in this case, the jaws 128, 130. Furthermore, the catheter feeder100 provides for a constant velocity advancement/retraction of theleader catheter 38 in comparison to other reciprocating devices, whichare more sinusoidal, and thus, do not lend themselves as well tomimicking the finger feeding performed by physicians. It should also beappreciated that, although the catheter feeder 100 is described ascomprising three jaw assemblies 120 a, 120 b, 120 c, an alternativecatheter feeder 100 may include only one jaw assembly 120. In this case,advancement and retraction of the catheter body 50 will not becontinuous, but will be intermittent.

Referring now to FIGS. 22 and 23, the grip adjustment assembly 104generally comprises a yoke 222 coupled to the second jaws 130 of thethree respective jaw assemblies 120 a, 120 b, 120 c, and a driverassembly 224 configured for actuating the yoke 222 to adjust thepositions of the stationary gripping pads 142, and thus, the gripbetween the gripping pads 140, 142.

To this end, the yoke 222 is mechanically coupled to the jaw actuators134 of the jaw assemblies 120, such that translation of the yoke 222along the transverse axis 118 corresponding translates the second jaws130 of all three jaw assemblies 120 along the transverse axis 118 inunison, while allowing the jaw assemblies 120 to translate relative toeach other along the longitudinal axis 116 within a limited range. Eachof the jaw actuators 134 includes a channel 226 extending along thelongitudinal axis 116, and the yoke 222 includes three pairs of bosses228, each pair being disposed within the channel 226 of a respective jawactuator 134.

Thus, translation of the yoke 222 along the transverse axis 118 causesthe channels 226 to bear against the bosses 228, thereby translating thejaw actuators 134, and thus, the second jaws 130 of the jaw assemblies120 along the transverse axis 118. The diameters of the bosses 228 areequal to the width of the respective channel 226 to provide closetolerance between the translations of the yoke 222 and second jaws 130along the transverse axis 118. The length of each channel 226 is greaterthan the longitudinal span of the respective pair of bosses 228, suchthat jaw actuators 134, and thus the jaw assemblies 120, can translaterelative to the yoke 222 along the longitudinal axis 116 within alimited range. In order to guide translation of yoke 222 along thetransverse axis 118, the grip adjustment assembly 104 further comprisesfour parallel rails 230 mounted to the base plate 106 along thetransverse axis 118, and the yoke 222 includes four channeled blocks 232for slidably receiving the rails 230 therein, as best shown in FIG. 23.It can be appreciated that the second jaws 130 can be translated awayfrom the first jaws 128 to loosen the grip between, or accommodate alarger diameter catheter body 50, and translated toward the first jaws128 to tighten the grip between, or accommodate a smaller diametercatheter body 50.

As best shown in FIG. 22, the driver assembly 224 generally comprises acam assembly 234 configured for actuating the yoke 222, a motor assembly236, and a drive train 238 operably coupled between the motor assembly236 and the cam assembly 234.

The cam assembly 234 is configured for translating the yoke 222 alongthe transverse axis 118, thereby translating the second jaws 130 towardor away from the first jaws 128 of the respective jaw assemblies 120. Tothis end, the cam assembly 234 generally comprises a bearing support240, a cam shaft 242 rotatably disposed within the bearing support 240,and a cam follower element 244 coupled between the cam shaft 242 and theyoke 222.

The bearing support 240 includes a bearing aperture 244 and a pair ofbearing rings 246 disposed within the bearing aperture 244. The camshaft 242 is mounted through the bearing rings (not shown) of thebearing support 240, such that the cam shaft 242 may rotate about alongitudinal axis extending through the center of the bearing aperture244.

The cam shaft 242 comprises a cam element 248 in the form of a rod thatis eccentric with the longitudinal axis of the cam shaft 242. The camfollower element 244 includes a first aperture 250 through which the camelement 248 is rotatably disposed, and a second aperture 252 in which across bar 254 (shown in FIG. 23) affixed to the yoke 222 is rotatablydisposed. Due to the eccentricity of the cam element 248 relative to thelongitudinal axis of the cam shaft 248, rotation of the cam shaft 248will cause the cam element 248 to orbit the longitudinal axis of the camshaft 242, thereby causing the cam follower element 244, and thus theyoke 222 via the cross bar 254, to alternately translate along thetransverse axis 118 in a reciprocating manner. Thus, rotation of the camshaft 242 in one direction will cause the yoke 222 to translate alongthe transverse axis 118, and further rotation of the cam shaft 242 inthe same direction will cause the yoke 222 to translate in the oppositedirection along the transverse axis 118, thereby adjusting the distancebetween the gripping pads 140, 142 of the respective jaw assemblies 120.A spring (not shown) may be optionally added to the assembly to havebetter control of the force applied to the leader catheter 76.

The motor assembly 236 comprises a motor 256, a motor mount 258 (only aportion of which is shown in FIG. 22) in which the motor 256 is mounted,and an electrical connector 260 configured for coupling the cable 24 tothe electronics within the motor 256, thereby allowing the motor 256 tobe controlled via the control station 16. The drive train 238 comprisesa drive pulley 262 mounted to the drive shaft (not shown) of the motor254, and a driven pulley 264 mounted to the cam shaft 242. The drivepulley 262 and driven pulley 264 are mechanically coupled to each othervia a drive belt (not shown). In the illustrated embodiment, each of thedrive and driven pulleys 262, 264 takes the form of a spur gear, inwhich case, the drive belt is cogged. Thus, the motor 256 can beoperated to rotate the drive pulley 262, which rotates the cam shaft242.

The loading/unloading assembly 105 generally comprises a switch handle266 mounted to the base plate 106, and a lever 268 mechanically coupledbetween the switch handle 266 and the motor mount 258. Significantly,the bearing support 240 and motor mount 258 are not mounted to the baseplate 106, but rather are affixed to each other in an integrated unitcapable of being translated relative to the base plate 106 along thetransverse axis 118. Accordingly, when the switch handle 266 is rotatedin a direction away from the jaw assemblies 120, the lever 268 likewisetranslates the motor mount 258 away from the jaw assemblies 120. As aresult, the bearing support 240, and thus the cam shaft 242 and camfollower element 244, will be translated away from the jaw assemblies120, thereby translating the second jaws 130 away from the first jaws128 of the jaw assemblies 120 via the yoke 222. In contrast, when theswitch handle 266 is rotated in a direction toward the jaw assemblies120, the lever 268 likewise translates the motor mount 258 toward thejaw assemblies 120. As a result, the bearing support 240, and thus thecam shaft 242 and cam follower element 244, will be translated towardthe jaw assemblies 120, thereby translating the second jaws 130 towardthe first jaws 128 of jaw assemblies 120 via the yoke 222.

It can be appreciated that the second jaws 130 can be translated awayfrom the first jaws 128 (via rotation of the switch handle 266 away fromthe jaw assemblies 120) to allow the catheter body 50 to be easilydropped into the respective jaw assemblies 120, and then translatedtoward the first jaws 128 (via rotation of the switch handle 266 towardthe jaw assemblies 120) to affix the catheter body 50 within therespective jaw assemblies 120, in effect allowing top loading of thecatheter body 50 into the catheter feeder 100. Then, the second jaws 130can be translated away from the first jaws 128 (via rotation of theswitch handle 266 away from the jaw assemblies 120) to allow thecatheter body 50 to be easily removed from the respective jaw assemblies120, in effect allowing top unloading of the catheter body 50 from thecatheter feeder 100.

Referring to FIG. 24, the drape 110 is integrated with the gripping pads140, 142, such the drape 110 and gripping pads 140, 142 form adisposable unit. In particular, the drape 110 includes a fold 270, withone side of the fold 270 being integrated with the three gripping pads140, and the other side of the fold 270 being integrated with the threegripping pads 142. Each of the gripping pads 140, 142 includes a pocket272 in which a respective one of the gripping flanges 136, 138 areremovably seated. Thus, prior to the medical procedure, the drape 110may be installed onto the catheter feeder 100 by clipping the grippingflanges 136, 138 into the pockets 272 of the respective gripping pads140, 142. After the medical procedure is completed, the drape 110 maythen be removed from the catheter feeder 100 by unclipping the grippingflanges 136, 138 from the pockets 272 of the respective gripping pads140, 142.

Having described the structure and function of the catheter feeder 100,its operation in advancing and retracting the leader catheter 38 withinthe guide sheath 36 will now be described. For purposes of clarity, theadvancement and retraction of the leader catheter 28 within the guidesheath 36 will first be described with respect to the operation of asingle jaw assembly 120.

With reference back to FIGS. 9, 15, and 16, to advance the leadercatheter 38 within the guide sheath 36, the cam shaft 158 iscontinuously rotated in the first rotational direction 166 via operationof the motor 149 to mimic the manual finger feed method that physiciansmay use to advance the leader catheter 38 within the guide sheath 36.

In particular, it is initially assumed that the jaw assembly 120 hasbeen translated the maximum predetermined distance in the second axialdirection 172. At this point, the linear cam 194 on the cam shaft 158 isengaging the first bearing surface 190 on the cam follower element 156,thereby continuing transition of the jaw assembly 120 from the openedposition to the closed position, the second helical cam 188 on the camshaft 158 has just disengaged the second groove 184 on the cam followerelement 156, thereby terminating linear translation of the jaw assembly120 in the second axial direction 172, and the first helical cam 186 onthe cam shaft 158 has just engaged the first groove 182 on the secondjaw 124, thereby initiating linear translation of the jaw assembly 120in the first axial direction 170 (the jaw assembly 120 has justcompleted the rear stroke and is initiating the front stroke) (see FIG.25a ).

The first helical cam 186 on the cam shaft 158 continues to engage thefirst groove 182 on the cam follower element 156, thereby linearlytranslating the jaw assembly 120 in the first axial direction 170, whilethe linear cam 194 on the cam shaft 158 continues to engage the firstbearing surface 190 on the cam follower element 156 until the jawassembly 120 is closed, thereby gripping the catheter body 50 (the jawassembly 120 completes the beginning stage of the front stroke) (seeFIG. 25b ). The first helical cam 186 on the cam shaft 158 continues toengage the first groove 182 on the second jaw 124, thereby linearlytranslating the closed jaw assembly 120 in the first axial direction170, and inserting the leader catheter 38 within the guide sheath 36(the jaw assembly 120 completes the middle stage of the front stroke)(see FIG. 25c ).

The linear cam 194 on the cam shaft 158 then disengages the firstbearing surface 190 on the cam follower element 156, and engages thesecond bearing surface 192 on the cam follower element 156, therebyinitiating transition of the jaw assembly 120 from the closed positionto the opened position and releasing the catheter body 50, while thefirst helical cam 186 on the cam shaft 158 continues to engage the firstgroove 182 on the cam follower element 156 until the jaw assembly 120translates the maximum distance in the first axial direction 170. Atthis point, the linear cam 194 on the cam shaft 158 is engaging thesecond bearing surface 192 on the cam follower element 156, therebycontinuing transition of the jaw assembly 120 from the closed positionto the opened position, the first helical cam 186 on the cam shaft 158has just disengaged the first groove 182 on the cam follower element156, thereby terminating linear translation of the jaw assembly 120 inthe first axial direction 170, and the second helical cam 188 on the camshaft 158 has just engaged the second groove 184 on the cam followerelement 156, thereby initiating linear translation of the jaw assembly120 in the second axial direction 172 (the jaw assembly 120 has justcompleted the front stroke and is initiating the rear stroke) (see FIG.25d ).

The second helical cam 188 on the cam shaft 158 continues to engage thesecond groove 184 on the cam follower element 156, thereby linearlytranslating the jaw assembly 120 in the second axial direction 172,while the linear cam 194 on the cam shaft 158 continues to engage thesecond bearing surface 192 on the cam follower element 156 until the jawassembly 120 is open, thereby fully releasing the catheter body 50 (thejaw assembly 120 completes the beginning stage of the rear stroke) (seeFIG. 25e ). The second helical cam 188 on the cam shaft 158 continues toengage the second groove 150 on the cam follower element 156, therebylinearly translating the closed jaw assembly 120 in the second axialdirection 172 (the jaw assembly 120 completes the middle stage of therear stroke) (see FIG. 25f ). The linear cam 194 on the cam shaft 158then disengages the second bearing surface 192 on the cam followerelement 156, and engages the first bearing surface 190 on the camfollower element 156, thereby initiating transition of the jaw assembly120 from the opened position to the closed position, while the secondhelical cam 188 on the cam shaft 158 continues to engage the secondgroove 184 on the cam follower element 156 until the jaw assembly 120translates the maximum distance in the second axial direction 172 (thejaw assembly 120 completes the end stage of the rear stroke) (see FIG.25g ).

Rotation of the cam shaft 158 may continue to be rotated in the firstrotational direction 166 to repeat the previous steps, thereby furtheradvancing the leader catheter 38 within the guide sheath 36. Thus, itcan be appreciated that the leader catheter 38 can be incrementallyadvanced within the guide sheath 36 via continuous rotation of the camshaft 158 in the first rotational direction 166.

To retract the leader catheter 38 within the guide sheath 36, the camshaft 158 is continuously rotated in the second rotational direction 168via operation of the motor 149 to mimic the manual finger retract methodthat physicians may use to retract the leader catheter 38 within theguide sheath 36. In particular, the same manipulation steps describedabove with respect to the advancement of the leader catheter 38 areperformed, with the caveat that the front stroke occurs in the secondaxial direction 172, and the rear stroke occurs in the first axialdirection 170.

Having described the technique for advancing and retracting the leadercatheter 38 within the guide sheath 36 using a single jaw assembly 120,one technique for advancing and retracting the leader catheter 38 withinthe guide sheath 36 using the three jaw assemblies 120 a, 120 b, 120 cwill now be described. Each of the jaw assemblies 120 a, 120 b, 120 ccan transition between the different stages of the front and rearstrokes in the same manner discussed above, but timed in a manner thatprovides continuous advancement/retraction of the leader catheter 38within the guide sheath 36.

It is initially assumed that jaw assembly 120 c is closed and beingtranslated in the first axial direction 170, thereby performing theleader catheter advancement function (the jaw assembly 120 c isinitiating the middle stage of its front stroke), the jaw assembly 120 bis transitioning from the opened position to the closed position andbeing translated in the second axial direction 172, thereby readying itto take over the leader catheter advancement function from the first jawassembly 120 a (the jaw assembly 120 b is in the end stage of its rearstroke), and the jaw assembly 120 a is transitioning from the closedposition to the opened position and being translated in the second axialdirection 172 (the jaw assembly 120 a is completing the middle stage ofits front stroke) (see FIG. 26a ).

Just prior to transitioning the jaw assembly 120 c from the closedposition to the opened position during its translation in the firstaxial direction 170 (the jaw assembly 120 c is completing the middlestage of its front stroke), the jaw assembly 120 b is transitioned fromthe opened position to the closed position while translating in thefirst axial direction 170, thereby taking over the leader catheteradvancement function from the jaw assembly 120 c (the jaw assembly 120 bcompletes the end stage of its rear stroke and the initial stage of itsfront stroke, and initiating the middle stage of its front stroke), andthe jaw assembly 120 a is transitioning from the opened position to theclosed position while continuing to be translated in the second axialdirection 172, thereby readying it to take over the leader catheteradvancement function from the jaw assembly 120 b (the jaw assembly 120 acompletes the end stage of its front stroke and the initial stage of itsrear stroke, and is in the end stage of its rear stroke) (see FIG. 26b).

Just prior to transitioning the jaw assembly 120 b from the closedposition to the opened position during its translation in the firstaxial direction 170 (the jaw assembly 120 b is completing the middlestage of its front stroke), the jaw assembly 120 a is transitioned fromthe opened position to the closed position while translating in thefirst axial direction 170, thereby taking over the leader catheteradvancement function from the jaw assembly 120 b (the jaw assembly 120 acompletes the end stage of its rear stroke and the initial stage of itsfront stroke, and is initiating the middle stage of its front stroke),and the jaw assembly 120 c is transitioning from the opened position tothe closed position while continuing to be translated in the secondaxial direction 172, thereby readying it to take over the leadercatheter advancement function from the jaw assembly 120 a (the jawassembly 120 c completes the end stage of its front stroke and theinitial stage of its rear stroke, and is in the end stage of its rearstroke) (see FIG. 26c ).

Just prior to transitioning the jaw assembly 120 a from the closedposition to the opened position during its translation in the firstaxial direction 170 (the jaw assembly 120 a is completing the middlestage of its front stroke), the jaw assembly 120 c is transitioned fromthe opened position to the closed position while translating in thefirst axial direction 170, thereby taking over the leader catheteradvancement function from the jaw assembly 120 a (the jaw assembly 120 ccompletes the end stage of its rear stroke and the initial stage of itsfront stroke, and is initiating the middle stage of its front stroke),and the second jaw assembly 120 a is transitioning from the openedposition to the closed position while continuing to be translated in thesecond axial direction 172, thereby readying it to take over the leadercatheter advancement function from the jaw assembly 120 c (the jawassembly 120 a completes the end stage of its front stroke and theinitial stage of its rear stroke, and is in the end stage of its rearstroke) (see FIG. 26d ).

Rotation of the cam shaft 158 may continue to be rotated in the firstrotational direction 166 to repeat the previous steps, thereby furtheradvancing the leader catheter 38 within the guide sheath 36. Thus, itcan be appreciated that the leader catheter 38 can be continuouslyadvanced within the guide sheath 36 via continuous rotation of the camshaft 158 in the first rotational direction 166.

To retract the leader catheter 38 within the guide sheath 36, the camshaft 158 is continuously rotated in the second rotational direction 168via operation of the motor to mimic the manual finger retract methodthat physicians may use to retract the leader catheter 38 within theguide sheath 36. In particular, the same manipulation steps describedabove with respect to the advancement of the leader catheter 38 areperformed, with the caveat that the front stroke occurs in the secondaxial direction 172, and the rear stroke occurs in the first axialdirection 170.

Referring to FIG. 27-50, another embodiment of an active catheter feeder300 will now be described. Unlike the catheter feeder 100 which utilizesopposing gripping pads that are linearly translated to activelyadvance/retract the leader catheter 38 within the guide sheath 36, thecatheter feeder 300 utilizes opposing gripping pads that are rotated toactively advance/retract the leader catheter 38 within the guide sheath36. The catheter feeder 300 is integrated into the housing 68 of theinstrument driver 34.

To this end, and with reference to FIGS. 27-30, the catheter feeder 300generally comprises a disposable rotatable gripper assembly 302 forperforming advancing/retracting movements of the leader catheter 38within the guide sheath 36, a driver assembly 304 configured foractuating the rotatable gripper assembly 302 to perform these movements,and a drape 306 (shown in FIGS. 39 and 40) configured for isolating thedisposable components of the catheter feeder 300 from the sterile field.

The rotatable gripper assembly 302 is mounted to the outside of thehousing 68 of the instrument driver 34 between the sheath drive block 74and the catheter carriage 76, and in particular, may be mounted to thesame mounting plate 70 (as the base plate) on which the proximal adapter48 is mounted. In contrast, the driver assembly 114 is contained withinthe housing 68 of the instrument driver 34.

Referring further FIGS. 31, 32, 42, and 43, the rotatable gripperassembly 302 includes an upper pair of upper opposable arms 308 a, 308 bpivotably mounted to a base (and in this case the mounting plate 70) viarespective rods 310, a pair of vertical shafts 312 rotatably mounted tothe respective upper arms 308 a, 308 b, and a pair of rotatable grippingpads 314 respectively mounted to the vertical shafts 312.

The base 316 of each of the upper arms 308 includes a bore 318 throughwhich the rod 310 is mounted. The rods 310 are rotatably mounted withinrespective apertures (not shown) within the mounting plate 70, such thatthe upper arms 308 are pivotably mounted to the mounting plate 70. Inthe illustrated embodiment, both arms 308 are capable of alternativelypivoting toward each other to grip the catheter body 50 (see FIGS. 31and 42) and away from each other to release the catheter body 50 (seeFIGS. 32 and 43). Alternatively, only one of the upper arms 308 a iscapable of pivoting toward or away from the other arm 308 b, which inthis case, the other arm 308 b cannot pivot relative to the mountingplate 70.

The end 320 of each of the upper arms 308 curves inward and include ahorizontal cavity 322 formed between a pair of horizontal flanges 324 inwhich the respective rotatable gripping pad 314 is disposed. The end 320of each of the upper arms 308 further includes a pair of bearingapertures 326 formed through the respective horizontal flanges 324 and apair of bearing rings 328 disposed within the respective bearingapertures 326 (only the apertures 326 and bearing rings 328 in the tophorizontal flanges 324 are shown in FIGS. 31 and 32). Each verticalshaft 312 is rotatably mounted through the pair of bearing rings 328disposed in the respective arm 308, so that each rotatable gripping pad314 is rotatably mounted in the horizontal cavity 322 of the respectivearm 308.

It can be appreciated that the upper arms 308, when completely pivotedaway from each other, allow the catheter body 50 to be top loaded intothe catheter feeder 300; that is, the catheter body 50 can simply belaterally placed (dropped in) between the rotatable gripping pads 314.It can be also be appreciated that the upper arms 308 can be pivotedtoward each other, such that the catheter body 50 can be gripped betweenthe rotatable gripping pads 314 (see FIGS. 31 and 42), and pivoted awayfrom each other, such that the catheter body 50 can be released frombetween the rotatable gripping pads 314 (see FIGS. 32 and 43).Furthermore, the opposing rotation of the rotatable gripping pads 314,when the catheter body 50 is gripped therebetween, advances or retractsthe leader catheter 38 within the guide sheath 36. Significantly,continuous rotation of the rotatable gripping pads 314 provides forinfinite advancement/retraction range of actuation for the leadercatheter 38.

To vertically center the catheter body 50 between the rotatable grippingpads 314, the end 320 of one of the upper arms 308 (in this case, theupper arm 308 b) further includes a claw feature 330 having an upperstraight flange 332, a lower L-shaped flange 334, and an L-shaped slot336 formed between the flanges 332, 334. The catheter body 50 can be toploaded into a vertical portion 338 of the L-shaped slot 336, and thenlaterally slid into a horizontal portion 340 of the L-shaped slot 336 toconveniently locate the catheter body 50 between the rotatable grippingpads 314. Thus, when the upper arms 308 are completely pivoted towardeach other, as shown in FIGS. 31 and 42, the slotted geometry verticallyconstrains the catheter body 50, while the rotatable gripping pads 314horizontally constrain the catheter body 50.

Significantly, the rotatable gripping pads 314 are specially designed todistribute the gripping force applied to the catheter body 50, therebypreventing pinching. As such, a relatively large gripping force can beapplied to the catheter body 50 to prevent slippage, as well as tocompensate for varying catheter diameters. In particular, as shown inFIGS. 33-36, each rotatable gripping pad 314 includes an outer circularrim 342 with a gripping surface 344, a center hub 346 to which therespective vertical shaft 312 is mounted, and a framework 348 disposedbetween the circular rim 342 and the center hub 346. The frameworks 348of the respective rotatable gripping pads 314 are configured forpartially collapsing in response to the gripping force generated whenthe arms 308 are pivoted toward each other, such that the portions ofthe rims 342 that oppose each other flatten to contact each other alongan extended line of contact to distribute the gripping force. Therotatable gripping pads 314 essentially deform to a D-shape, as bestshown in FIG. 35. In the illustrated embodiment, each of the frameworks348 includes a plurality of spokes 350 extending between the center hub346 and the circular rim 342. All of the spokes 350 are curved in thesame direction, such that they collapse onto each other in response tothe gripping force, and in particular, bend and stack on top of eachother. In alternative embodiments, other types of frameworks, such as ahoneycomb pattern, may be used; however, the simple spoke design is moreeasily manufacturable.

The thickness of the spokes 350 is preferably within a range thatfacilitates their collapse in response to minimal gripping force. Forexample, each spoke 350 may have a thickness in the range of 0.010-0.050inches. In the illustrated embodiment, each spoke 350 has a 0.040 inchthickness. The circular rim 342 and framework 348 may be overmolded onthe hub 346, and may be composed of a suitable material, such as rubber.The durometer/hardness of the material is preferably high enough toendure high friction (preferably at least 50 A), while being low enoughto facilitate collapsing of the spokes 350 and circular rim 342 in thepresence of the gripping force. A thermoplastic polyurethane, such asTexin® RxT70A, is ideal for high friction applications and is furthergamma compliant. Each rotatable gripping pad 314 preferably has adiameter of two inches or less and a width of less than one inch. In theillustrated embodiment, each rotatable gripping pad 314 has a 1.0 inchdiameter and a 0.38 inch width. Thus, it can be appreciated that incomparison to a rotatable gripping pad composed of soft rubber where alot of gripping force is required to compress and create a small amountof contact, and thus small gripping force, between the rotatablegripping pads, the architecture of the rotatable gripping pads 314provides a large gripping force without pinching the catheter body 50.In essence, the rotatable gripping pads 314 collapse as opposed tocompress as with solid rotatable gripping pads. As best shown in FIGS.34 and 36, the gripping surfaces 344 of the respective rims 342 may beconcave in order to facilitate vertical centering of the catheter body50 between the rotatable gripping pads 314.

As shown in FIGS. 37 and 38, each of the rotatable gripping pads 314 mayoptionally include a pair of upper and lower sprockets 352 mounted tothe opposing flat upper and lower surfaces of the respective rotatablegripping pad 314. Each sprocket 352 includes a plurality ofcircumferentially disposed teeth 354. As such, the upper sprockets 352of the rotatable gripping pads 314 interlace or mesh with each other,and the lower sprockets 352 of the rotatable gripping pads 314 interlaceor mesh with each other. In this manner, the catheter body 50 isprevented from slipping out from between the rotatable gripping pads314, which might otherwise occur due as a result of inconsistentpressure across the width of the rotatable gripping pads 314 due totheir collapsing nature. In the illustrated embodiment, the rotatablegripping pads 314, including the sprockets 352, are composed of ahomogenous material, so that deformation of the sprockets 352 trackswith the deformation of the rims 342 and spokes 350 of the respectiverotatable gripping pads 314. In an alternative embodiment, the sprockets352 are composed of a material that is more rigid than the material ofwhich the circular rim 342 and spokes 350 is composed. In this manner,one of the rotating rotatable gripping pads 314 may drive the otherrotatable gripping pad 314 to rotate it.

Pivoting of the upper arms 308 and rotation of the rotatable grippingpads 314 are actuated via the driver assembly 304. Referring now toFIGS. 39-41, the rotatable gripper assembly 302 is configured forinterfacing with the driver assembly 304 via the sterile drape 306surrounding the housing 68. In particular, the sterile drape 306includes a pair of plugs 356 capable of being respectively disposed overa pair of collars 386 of the driver assembly 304. The vertical shafts312 of the rotatable gripper assembly 302 may then be respectivelyslipped through the plugs 356 and into the collars 386 of the driverassembly 304. The end of each of the vertical shafts 312 includes akeyed feature, such as a boss or cross pin, that engages a correspondingkeyed feature in respective apertures in the collars 386. As will bedescribed in further detail below, the driver assembly 304 rotates thecollars 386 in opposing directions to correspondingly rotate therotatable gripping pads 314 in opposite directions, as well asalternately displacing the collars 386 toward and away from each otherto correspondingly pivot the upper arms 308 toward and away from eachother. The sterile drape 306 folds or collapses between the plugs 356when the arms 308 are pivoted towards each other (i.e., the plugs 356are translated toward each other) (see FIG. 39), and unfolds or expandswhen the arms 308 are pivoted away from each other (i.e., the plugs 356are translated away from each other) (see FIG. 40). To facilitate itsfolding/collapsing or unfolding/expansion, the sterile drape 306includes an expansion joint 358 between the plugs 356. As best shown inFIG. 50, the upper arms 308 respectively include bosses 359 thatrespectively slip over the plugs 356 (not shown in FIG. 50) to create alabyrinth seal, thereby preventing fluid ingress into the housing 68.

As shown in FIGS. 27-30, the driver assembly 304 generally comprises apair of lower opposable arms 360 a, 360 b configured for being actuatedto pivot the respective upper arms 308 a, 308 b and to rotate therotatable gripping pads 314 of the rotatable gripper assembly 302, afirst motor assembly 362, a drive train 364 operably coupled between thefirst motor assembly 362 and the lower opposable arms 360 a, 360 b, asecond motor assembly 366, and a gripping force adjustment mechanism 368operably coupled between the second motor assembly 366 and the loweropposable arms 360 a, 360 b.

Referring back to FIGS. 39 and 40, each of the lower arms 360 includes apair of horizontal flanges 370 and a horizontal cavity 372 formedbetween the horizontal flanges 370. The base 374 of each of the lowerarms 360 further includes a boss 376 formed on the top horizontal flange370 and a bearing aperture 378 formed within the boss 376. Each of thetwo rods 310 of the rotatable gripper assembly 370 includes a boss (notshown) that is rotatably mounted within the bearing aperture 372 of therespective lower arm 360, so that the lower arms 360 are pivotablymounted to the respective rods 310. Thus, the lower arms 360 mayalternately pivot toward (see FIG. 39) and away (see FIG. 40) from eachother about the vertical rods 310.

The end 380 of each of the lower arms 360 further includes a pair ofbearing apertures 382 formed through the respective horizontal flanges370 and a pair of bearing rings 384 disposed within the respectivebearing apertures 382 (only the apertures 382 and bearing rings 384 inthe top horizontal flanges 370 are shown in FIGS. 39 and 40). The ends380 of the respective lower arms 360 further includes the previouslydescribed collars 386 to which the respective vertical shafts 312 of therotatable gripper assembly 302 mate as discussed above. The collars 386are rotatably mounted through the respective bearing rings 384 of thetop horizontal flanges 370. In this manner, pivoting of the each of thelower arms 360 correspondingly pivots the respective upper arm 308 towhich it is coupled via the mating arrangement of the vertical shaft 312and collar 386. The lower arms 360 respectively pivot about the sameaxes as the upper arms 308, such that the upper arms 308 will pivot inunison with the lower arms 360. As will be described in further detailbelow, one of the lower arms 360, and in this case, the lower arm 360 a,is driven to alternately pivot towards and away from the other lower arm360 b. The bases 374 of the lower arms 360 engage each other via sectiongears 388 that engage each other, such that the other lower arm 360 bpivots in a direction opposite to the direction in which the lower arm360 a pivots. In effect, the lower arm 360 a pivots the other lower arm360 b in the opposite direction via the section gears 388.

As shown in FIGS. 27-30, the first motor assembly 362 comprises a motor390, a motor mount (not shown) in which the motor 390 is mounted, and anelectrical connector 392 configured for coupling the cable 24 to theelectronics within the motor 390, thereby allowing the motor 390 to becontrolled via the control station 16. The drive train 364 is coupledbetween the motor 390 and the lower arms 360 in a manner that rotatesthe collars 386, and thus the rotatable gripping pads 314 of therotatable gripper assembly 302, in opposite directions.

To this end, and with reference to FIGS. 39, 40, and 42-46, the drivetrain 364 comprises a gear assembly 392 disposed within the horizontalcavities 372 of the lower arms 360. The gear assembly 392 includes aneven number of gears to create opposing motion in the rotatable grippingpads 314 via rotation of the collars 386 and corresponding rotation ofthe vertical shafts 312. In particular, the gear assembly 392 includeseight gears 392 a-392 h arranged in a linear cluster within thehorizontal cavities 372 of the lower arms 360. Four of the gears (gears392 e-392 h) are located in the lower arm 360 a, and the other fourgears (gears 392 a-392 d) are located in the lower arm 360 b.Ultimately, the number of gears 392 will be dictated by the packaging ofthe lower arms 360 within the housing 68. Each of the gears 392 a-392 hare rotatably mounted within the lower arms 360 via a corresponding pairof bearing apertures 382 formed through the horizontal flanges 370 andthe pair of bearing rings 384 disposed within the bearing apertures(bearing apertures and bearing rings not shown for the gears 392 c and392 d).

The rotatable gripping pad gear 392 a is coupled to the drive gear 392 cvia the gear 392 b, such that rotation of the drive gear 392 a rotatesthe gear 392 b, which in turn rotates the rotatable gripping pad gear392 a. Likewise, the rotatable gripping pad gear 392 h is coupled to thedrive gear 392 c via the gears 392 d-392 g, such that rotation of thedrive gear 39 ca rotates the gear 392 d, which in turn rotates the gear392 e, which in turn rotates the gear 392 f, which in turn rotates thegear 392 g, which in turn rotates the rotatable gripping pad gear 392 h.Because there is an even number of gears in the gear assembly 392, therotatable gripping pad gears 392 a, 392 h, and thus the rotatablegripping pads 314, rotate in opposite directions when the drive gear 392c is rotated in either direction. It can be appreciated that rotation ofthe drive gear 392 c in one direction 394 will cause the rotatablegripping pads 314 to rotate in a manner that advances the leadercatheter 38 within the guide sheath 36, and rotation of the drive gear392 c in the opposite direction 396 will cause the rotatable grippingpads 314 to rotate in a manner that retracts the leader catheter 38within the guide sheath 36. The middle gears 392 b and 392 g orbit aboutthe respective gears 392 c and 392 f as the lower arms 360 pivot away ortoward each other. In this manner, the rotatable gripping pad gears 392a, 392 h will always maintain transmission during pivoting of the lowerarms 360.

Referring back to FIGS. 27-30, the drive train 364 further comprises adrive shaft 398 to which the motor 390 is mechanically coupled, avertical rod 400 to which the drive gear 392 c is affixed, and a set ofbevel gears 402 coupling the drive shaft 398 to the vertical rod 400.Thus, operation of the motor 390 rotates the drive shaft 398, whichrotates the vertical rod 400, which in turn, rotates the drive gear 392c, thereby rotating the rotatable gripping pads 314, as described above.

The second motor assembly 366 comprises a motor 404, a motor mount (notshown) in which the motor 404 is mounted, and an electrical connector406 configured for coupling the cable 24 to the electronics within themotor 404, thereby allowing the motor 404 to be controlled via thecontrol station 16. The gripping force adjustment mechanism 368 iscoupled between the motor 404 and the lower arms 360 in a manner thatalternately pivots the upper arm 308 a (via the lower arm 360 a) in afirst direction (i.e., toward the other upper arm 308 b), such that thecatheter body 50 can be gripped between the rotatable gripping pads 314,and in a second opposite direction (i.e., away from the other upper arm308 b), such that the catheter body 50 can be released from between therotatable gripping pads 314. The gripping force adjustment mechanism 368is also coupled between the motor 404 and the lower arms 360 in a mannerthat adjusts the gripping force of the upper arms 308 when gripping thecatheter body 50.

To this end, and with reference to FIGS. 44-49, the gripping forceadjustment mechanism 368 further comprises a linkage in the form of avertical rod 408 affixed to the base 374 of the lower arm 360 a, and alever arm 410 affixed to the vertical rod 408, such that rotation of thelever arm 410 rotates the vertical rod 408 about its longitudinal axis,thereby placing a torque on the base 374 of the lower arm 360 a, andpivoting the lower arm 360 a (and thus the upper arm 308 a) toward oraway from the other lower arm 360 b (and thus the other upper arm 308b). The gripping force adjustment mechanism 368 further comprises ahorizontal rod 412 that is coupled to the lever arm 410. In particular,the lever arm 410 includes a through slot 414 in which a pin 416 can betranslated via a pair of rotatable gripping pads 418 through which thepin 416 is mounted (only one of the rotatable gripping pads 418 shown).The end of the horizontal rod 412 includes an aperture (not shown)through which the pin 416 is affixed, such that translation of thehorizontal rod 412 back and forth alternately pivots the lever arm 410while the pin 416 translate within the through slot 414 via therotatable gripping pads 418.

The gripping force adjustment mechanism 368 further comprises a leadscrew 420, and a lead nut 422 having a first threaded bore 424 in whichthe lead screw 420 is in threaded engagement, and a second bore 426 inwhich the horizontal rod 412 is in bearing engagement. The grippingforce adjustment mechanism 368 further comprises a compression spring428 disposed about the horizontal rod 412 between a pair of annularflanges 430, 432, with the spring 428 being disposed about thehorizontal rod 412 between the annular flanges 430, 432, and the leadnut 422 being disposed between the spring 428 and the annular flange432. The gripping force adjustment mechanism 368 further comprises apair of retaining devices 434 that maintain the horizontal rod 412 andthe lead screw 420 in parallel arrangement with each other.

Thus, it can be appreciated that the motor 404 can alternately actuatethe lever arm 410 via compression of the spring 428 to pivot the upperarm 308 a (via the lower arm 360 a) in a first direction (i.e., towardthe other upper arm 308 b), such that the catheter body 50 can begripped between the rotatable gripping pads 314, and in a secondopposite direction (i.e., away from the other upper arm 308 b), suchthat the catheter body 50 can be released from between the rotatablegripping pads 314. The motor 404 may also actuate the lever arm 410 tovary the compression of the spring 428 to adjust the gripping force ofthe upper arms 308 when gripping the catheter body 50.

In particular, rotation of the lead screw 420 via operation of the motor404 actuates the lower arms 360, and thus the upper arms 308, to pivotaway or toward each other. That is, as shown in FIGS. 46 and 48,rotation of the lead screw 420 in one direction 434 linearly displacesthe lead nut 422 in the direction 438, which compresses the spring 428.The compressed spring 428 bears against the annular flange 430, therebytranslating the horizontal rod 412 in the same direction 438, which inturn rotates the lever arm 410 in the direction 442, and rotates thevertical rod 408 about its longitudinal axis in the same direction 442to pivot the lower arms 360 (and thus the upper arms 308) toward eachother. In contrast, as shown in FIGS. 47 and 49, rotation of the leadscrew 420 in the opposite direction 436 linearly displaces the lead nut422 in the direction 440, which bears against the annular flange 432,thereby translating the horizontal rod 412 in the same direction 440,which in turn rotates the lever arm 410 in the direction 444, androtates the vertical rod 408 about its longitudinal axis in the samedirection 444 to pivot the lower arms 360 away from each other (and thusthe upper arms 308).

Assuming that the upper arms 308 are already gripping the catheter body50, further rotation of the lead screw 420 in the one direction 432further linearly displaces the lead nut 422 in the direction 436, whichfurther compresses the spring 428. The increased compression force ofthe spring 428 naturally increases the gripping force between the upperarms 308. In contrast, rotation of the lead screw 420 in the oppositedirection 434 linearly displaces the lead nut 422 back in the direction438, which decompresses the spring 428. The decreased compression forceof the spring 428 naturally decreases the gripping force between theupper arms 308. Preferably, to enhance controllability of the grippingforce between the upper arms 308 when gripping the catheter body 50, thecompression of the spring 428 is proportional to the gripping force.

Although the active catheter feeders 100 and 300 have been describedabove as being mechanisms for manipulating the advancing/retracting theleader catheter 38 within the guide sheath 36, it should be appreciatedthat the mechanisms described with respect to the active catheterfeeders 100 and 300 can alternatively or optionally be used in theguidewire feeder 82 to advance/retract the guidewire 40 within theleader catheter 38. Furthermore, an alternative embodiments, an activesheath feeder (not shown), which may be identical to the active catheterfeeders described herein, may be located at the patient site to preventbuckling of the guide sheath 36 when inserted into the patient. Such anactive sheath feeder may manipulate the guide sheath 36 in the samemanner as the leader catheter 38 is manipulated by any of the activecatheter feeders described herein, and may operate in conjunction withthe displacement of entire robotic catheter assembly 18 relative to thesupport-arm assembly 14, or alternatively in conjunction with thedisplacement of a sheath carriage (not shown).

Although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

What is claimed is:
 1. A medical system, comprising: a telescopingcatheter assembly, comprising an outer sheath and an inner catheter, theouter sheath including an elongate sheath body and a sheath adapteraffixed to a proximal end of the sheath body, and the inner catheterincluding an elongate catheter body and a catheter adapter affixed to aproximal end of the catheter body; and an instrument driver comprising:a sheath interface configured for mating with the sheath adapter; aslidable carriage configured for mating with the catheter adapter; afeeder mechanism affixed between the sheath interface and the slidablecarriage and engageable with the catheter body, the feeder mechanismcomprising: a pair of rotatable gripping pads, and a pair of armsconfigured to pivot the pair of rotatable gripping pads towards eachother to engage with the catheter body and away from each other todisengage from the catheter body; and at least one motor configured fortranslating the slidable carriage toward the sheath interface totranslate the catheter adapter toward the sheath adapter via a firstactuator while operating the feeder mechanism to actively advance thecatheter body within the sheath body via a second actuator, the secondactuator being different from the first actuator, wherein each of thepair of arms comprises a section gear and the pair of arms are coupledto each other via the section gears such that pivoting one of the pairof arms pivots the other of the pair of arms in an opposite direction.2. The medical system of claim 1, wherein the at least one motor isconfigured for translating the slidable carriage away from the sheathinterface to translate the catheter adapter away from the sheath adapterwhile operating the feeder mechanism to actively retract the catheterbody within the sheath body.
 3. The medical system of claim 1, whereinthe sheath adapter and the catheter adapter are releasably engageablewith the sheath interface and slidable carriage, respectively.
 4. Themedical system of claim 1, wherein the pair of rotatable gripping padsare rotatable opposite to each other to actively advance the catheterbody within the sheath body.
 5. The medical system of claim 1, whereinthe telescoping catheter assembly further comprises a guidewire insidethe inner catheter, and the instrument driver further comprises a drivemechanism engageable with the guidewire, the drive mechanism configuredto advance and retract the guidewire within the catheter body.
 6. Amedical system, comprising: a telescoping catheter assembly, thetelescoping catheter assembly comprising an outer sheath and an innercatheter, the outer sheath including an elongate sheath body and asheath adapter affixed to a proximal end of the sheath body, wherein thesheath adapter comprises one or more drive shafts to tension or releasepullwires disposed within the outer sheath body, and the inner catheterincluding an elongate catheter body and a catheter adapter affixed to aproximal end of the catheter body; and an instrument driver comprising:a sheath interface configured to mate with the sheath adapter; amateable interface configured to mate with the catheter adapter; and afeeder mechanism affixed between the sheath interface and the mateableinterface, the feeder mechanism engageable with the catheter body of theinner catheter to actively advance the inner catheter within the sheathbody, the feeder mechanism comprising at least one arm configured topivot towards the catheter body to engage with the catheter body andaway from the catheter body to disengage from the catheter body, whereinthe feeder mechanism further comprises a rotatable gripping pad coupledto a drive gear via a gripping pad gear, wherein pivoting the at leastone arm causes the gripping pad gear to rotate about the drive gear. 7.The medical system of claim 6, wherein the feeder mechanism is furtherconfigured to actively retract the inner catheter within the sheathbody.
 8. The medical system of claim 6, wherein the sheath adapter andthe catheter adapter are releasably engageable with the sheath interfaceand mateable interface, respectively.
 9. The medical system of claim 6,wherein the rotatable gripping pad comprises a first rotatable grippingpad and the feeder mechanism comprises a second rotatable gripping padopposing the first rotatable gripping pad, the first and secondrotatable gripping pads engagable with the catheter body of the innercatheter and rotatable opposite to each other to actively advance theinner catheter within the sheath body.
 10. The medical system of claim6, wherein the telescoping catheter assembly further comprises aguidewire, and the instrument driver further comprises a drive mechanismengageable with the guidewire and configured to advance and retract theguidewire within the inner catheter.
 11. The medical system of claim 10,wherein the drive mechanism is configured to simultaneously advance theguidewire within the catheter body and roll the guidewire about alongitudinal axis.
 12. The medical system of claim 6, wherein the feedermechanism is affixed relative to the sheath interface.
 13. The medicalsystem of claim 6, wherein the instrument driver is a robotic instrumentdriver, the medical system further comprising: a master input deviceconfigured for receiving commands from a user; and a computer configuredfor controlling the robotic instrument driver in accordance with theuser commands.
 14. The medical system of claim 6, wherein the instrumentdriver further comprises at least one motor configured for translatingthe mateable interface toward the sheath interface to translate thecatheter adapter toward the sheath adapter.
 15. A medical system,comprising: an outer sheath; an inner catheter; a sheath interfaceconfigured for mating with the sheath; a carriage configured for matingwith the catheter; a feeder mechanism between the sheath interface andthe carriage and engageable with the catheter, the feeder mechanismcomprising an arm configured to pivot towards the catheter to engagewith the catheter and away from the catheter to disengage from thecatheter; and at least one motor configured for translating the carriagetoward the sheath interface while the feeder mechanism is operated toadvance the catheter within the sheath, wherein the feeder mechanismfurther comprises a rotatable gripping pad coupled to a drive gear via agripping pad gear, wherein pivoting the arm causes the gripping pad gearto rotate about the drive gear.
 16. The medical system of claim 15,wherein the arm is a first arm, the feeder mechanism further comprises asecond arm configured to pivot towards the first arm to engage with thecatheter and away from the first arm to disengage from the catheter. 17.A medical system, comprising: an outer sheath; an inner catheter; asheath interface configured for mating with the sheath; a carriageconfigured for mating with the catheter; a feeder mechanism between thesheath interface and the carriage and engageable with the catheter, thefeeder mechanism comprising a first arm configured to pivot towards thecatheter to engage with the catheter and away from the catheter todisengage from the catheter, and a second arm configured to pivottowards the first arm to engage with the catheter and away from thefirst arm to disengage from the catheter; and at least one motorconfigured for translating the carriage toward the sheath interfacewhile the feeder mechanism is operated to advance the catheter withinthe sheath, wherein the first arm comprises a first section gear,wherein the second arm comprises a second section gear coupled to thefirst section gear, and wherein pivoting the first arm causes the secondarm to pivot in an opposite direction via engagement of the first andsecond section gears.